<HTML>
<HEAD>
     <TITLE></TITLE>
</HEAD>
<BODY STYLE="font: 10pt Times New Roman, Times, Serif">

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">UNITED STATES</P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">SECURITIES AND EXCHANGE COMMISSION</P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">WASHINGTON, D.C. 20549</P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">FORM 8-K</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>CURRENT REPORT </B></P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Date of Report (Date of earliest event reported):
July 10, 2012</P>

<P STYLE="font: normal 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: normal 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font-family: Times New Roman, Times, Serif">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 25%; font-size: 10pt; font-weight: bold; text-decoration: none">&nbsp;</TD>
    <TD STYLE="width: 50%; border-bottom: windowtext 1pt solid; font-size: 10pt; font-weight: bold; text-decoration: none; text-align: center"><FONT STYLE="font-weight: normal; font-style: normal">AMERICAN
    BIO MEDICA CORPORATION</FONT></TD>
    <TD STYLE="width: 25%; font-size: 10pt; font-weight: bold; text-decoration: none">&nbsp;</TD></TR>
</TABLE>


<P STYLE="font: normal 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Exact name of registrant as specified
in its charter)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font-family: Times New Roman, Times, Serif">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 34%; border-bottom: windowtext 1pt solid; font-weight: bold; text-decoration: none; text-align: center"><FONT STYLE="font-size: 10pt; font-weight: normal; font-style: normal">New
    York</FONT></TD>
    <TD STYLE="width: 2%; text-autospace: none; font-size: 10pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 31%; border-bottom: windowtext 1pt solid; text-autospace: none; font-size: 10pt; text-align: center">0-28666</TD>
    <TD STYLE="width: 2%; text-autospace: none; font-size: 10pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 31%; border-bottom: windowtext 1pt solid; text-autospace: none; font-size: 10pt; text-align: center">14-1702188</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(State or other jurisdiction</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">of incorporation)</P></TD>
    <TD STYLE="text-autospace: none; font-size: 10pt; text-align: center">&nbsp;</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Commission File</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Number)</P></TD>
    <TD STYLE="text-autospace: none; font-size: 10pt; text-align: center">&nbsp;</TD>
    <TD>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(IRS Employer</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Identification Number)</P></TD></TR>
</TABLE>
<P STYLE="font: normal 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: normal 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><U>122 Smith Road, Kinderhook, NY&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
 12106</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Address of principal executive offices)
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(Zip Code)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Registrant&rsquo;s telephone number, including
area code: 518-758-8158</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><U>Not applicable </U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Former name or former address, if changed
since last report.)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (<U>see</U> General Instruction
A.2. below):</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in"><FONT STYLE="font: 10pt Wingdings">&uml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in"><FONT STYLE="font: 10pt Wingdings">&uml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) </FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in"><FONT STYLE="font: 10pt Wingdings">&uml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) </FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in"><FONT STYLE="font: 10pt Wingdings">&uml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>

<!-- Field: Page; Sequence: 1 -->
    <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1pt solid"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%">&nbsp;</TD></TR></TABLE></DIV>
    <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%">&nbsp;</TD></TR></TABLE></DIV>
    <!-- Field: /Page -->

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Item 1.01&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Entry
into a Material Definitive Agreement</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On July 10, 2012, American
Bio Medica Corporation (the &ldquo;Company&rdquo;) announced in a press release that it has entered into a Consent Decree with
the U.S. Food and Drug Administration (&ldquo;FDA&rdquo;). As of the date of this report, the Consent Decree still must be approved
by the United States District Court for the Northern District of New York.</P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Item 8.01 <FONT STYLE="font-weight: normal">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</FONT>Other
Events</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><U>Risk Factor Disclosure</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to the disclosure provided under
Item 1.01, the Company is providing the following risk factor related to the Company&rsquo;s business:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><I>&nbsp;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><I>Any adverse changes in our regulatory
framework could negatively impact our business, and we are currently operating under a Consent Decree with the U.S. Food and Drug
Administration (FDA) related to selling our OralStat product in workplace settings. </I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our urine point of collection products
have received 510(k) marketing clearance from the FDA, and have therefore met FDA requirements for professional use. Our oral fluid
point of collection products have not received 510(k) marketing clearance from the FDA. We have also been granted a CLIA waiver
from the FDA related to our Rapid TOX product line. Workplace and Government are the Company&rsquo;s primary markets, and it has
been our belief (based on advice from FDA counsel) that marketing clearance from FDA is not required to sell our drug tests in
non-clinical (i.e. non-medical) markets (such as workplace and criminal justice/law enforcement), but is required to sell our products
in the clinical and over-the-counter (consumer) markets. We do not sell our oral fluid drug tests in clinical or over-the-counter
(consumer) markets. In addition, there are many other oral fluid point of collection drug tests currently being sold in the Workplace
market by our competitors, none of which have received FDA marketing clearance.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">However, in July 2009, we received a warning
letter from the FDA, which alleges we are marketing our point of collection oral fluid drug test, OralStat, in workplace settings
without marketing clearance or approval (see Current Report on Form 8-K filed with the SEC on August 5, 2009).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company communicated to the FDA its
belief (based on legal opinion) that marketing clearance was not required in non-clinical markets. FDA continued to disagree with
the Company&rsquo;s interpretation of FDA regulations related to medical devices, and the FDA continued to assert jurisdiction
of drug testing performed in the workplace. The Company also advised FDA that it was willing to obtain marketing clearance but
that specific technical and scientific issues existed when attempting to utilize FDA&rsquo;s draft guidance for the Company&rsquo;s
OralStat (because the draft guidance was written for urine drug tests). Nevertheless, the Company and FDA were unable to reach
a consensus on neither the jurisdiction issue nor the technical issues.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<!-- Field: Page; Sequence: 2 -->
    <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1pt solid"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%">&nbsp;</TD></TR></TABLE></DIV>
    <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%">&nbsp;</TD></TR></TABLE></DIV>
    <!-- Field: /Page -->

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On July 10, 2012 the Company announced
that it has entered into a Consent Decree with FDA. Under the terms of the Consent Decree, the Company will be allowed to continue
to market its OralStat drug test in the workplace market while it takes action to obtain a 510(k) marketing clearance. More specifically,
FDA will provide the Company with its most recent guidance on the clinical and analytical studies that need to be conducted to
gather data in support of a 510(k) submission for OralStat. The Company will then have a total of 396 days to discuss protocols
with FDA, complete its analytical and clinical studies and submit a substantially complete 510(k). The Company has agreed to withdraw
the OralStat product from the workplace market if any of the following events occur: 1) the Company does not submit a substantially
complete 510(k) within this specified time period, 2) the Company fails to submit additional information within time frames specified
by FDA, 3) the Company withdraws its submission, or 4) the Company&rsquo;s 510(k) submission results in FDA&rsquo;s determination
that the product is not substantially equivalent.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The cost of obtaining marketing clearance
is expected to be material and incurring such cost will have a negative impact on the Company&rsquo;s efforts to improve its performance
and to achieve profitability. Furthermore, there can be no assurance that we will obtain marketing clearance from the FDA and as
outlined in the Consent Decree, if we are unable to file our application within the time frame FDA requires, or if we are unable
to obtain marketing clearance for the OralStat, we will be forced to stop selling the OralStat product in the Workplace market.
Our point of collection oral fluid drug tests historically account for a material portion of our sales, with sales of oral fluid
drug tests accounting for approximately 20% of our sales in the last two completed fiscal years (the majority of which were sales
to the Workplace market). An inability to market and sell our point of collection oral fluid drug tests in the Workplace market
will negatively impact our revenues.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Although we are currently unaware of any
additional changes in regulatory standards related to any of our markets, if regulatory standards were to further change in the
future, there can be no assurance that the FDA will grant the Company appropriate marketing clearances required to comply with
the changes, if and when we apply for them. We will continue to take the necessary actions that will enable the Company to submit
a marketing clearance application to the FDA, and/or any additional actions that may be required to address the jurisdictional
question raised by our counsel.</P>

<P STYLE="font: bold 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 8%; font-weight: bold; text-align: left">Item 9.01</TD>
    <TD STYLE="width: 2%; font-weight: bold">&nbsp;</TD>
    <TD STYLE="width: 90%; font-weight: bold">Financial Statements and Exhibits</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-autospace: none; text-align: right">&nbsp;</TD>
    <TD STYLE="text-autospace: none; text-align: justify">&nbsp;</TD>
    <TD STYLE="text-autospace: none; text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-autospace: none; text-align: right">(d)</TD>
    <TD STYLE="text-autospace: none; text-align: justify">&nbsp;</TD>
    <TD STYLE="text-autospace: none; text-align: justify">Exhibits</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-autospace: none; text-align: right">&nbsp;</TD>
    <TD STYLE="text-autospace: none; text-align: justify">&nbsp;</TD>
    <TD STYLE="text-autospace: none; text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-autospace: none; text-align: right">&nbsp;</TD>
    <TD STYLE="text-autospace: none; text-align: justify">&nbsp;</TD>
    <TD STYLE="text-autospace: none; text-align: justify">Exhibit 99.1 Press Release dated July 10, 2012</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<!-- Field: Page; Sequence: 3 -->
    <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1pt solid"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%">&nbsp;</TD></TR></TABLE></DIV>
    <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%">&nbsp;</TD></TR></TABLE></DIV>
    <!-- Field: /Page -->

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">SIGNATURES</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="text-align: justify">AMERICAN BIO MEDICA CORPORATION (Registrant)</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 40%; text-autospace: none">Dated: July 10, 2012</TD>
    <TD STYLE="width: 4%; text-autospace: none">By:</TD>
    <TD STYLE="width: 56%; border-bottom: windowtext 1pt solid; padding-left: 0.25in; text-autospace: none">/s/ Melissa A. Waterhouse</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-autospace: none">&nbsp;</TD>
    <TD STYLE="text-autospace: none">&nbsp;</TD>
    <TD STYLE="padding-left: 0.25in; text-autospace: none">Melissa A. Waterhouse</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-autospace: none">&nbsp;</TD>
    <TD STYLE="text-autospace: none">&nbsp;</TD>
    <TD STYLE="padding-left: 0.25in; text-autospace: none">EVP, Regulatory Affairs</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-autospace: none">&nbsp;</TD>
    <TD STYLE="text-autospace: none">&nbsp;</TD>
    <TD STYLE="padding-left: 0.25in; text-autospace: none">Chief Compliance Officer</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-autospace: none">&nbsp;</TD>
    <TD STYLE="text-autospace: none">&nbsp;</TD>
    <TD STYLE="padding-left: 0.25in; text-autospace: none">Corporate Secretary</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<!-- Field: Page; Sequence: 4; Options: Last -->
    <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1pt solid"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%">&nbsp;</TD></TR></TABLE></DIV>
    <!-- Field: /Page -->

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

</BODY>
</HTML>
[{"type": "8-K", "sequence": "1", "filename": "v318077_8k.htm", "description": "FORM 8-K", "secsgml_size_bytes": 22150}]
{"company-data": {"conformed-name": "AMERICAN BIO MEDICA CORP", "cik": "0000896747", "assigned-sic": "2834", "irs-number": "141702188", "state-of-incorporation": "NY", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "000-28666", "film-number": "12954642"}, "business-address": {"street1": "122 SMITH ROAD", "city": "KINDERHOOK", "state": "NY", "zip": "12106", "phone": "5187588158"}, "mail-address": {"street1": "122 SMITH ROAD", "city": "KINDERHOOK", "state": "NY", "zip": "12106"}}
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
July 10, 2012
AMERICAN
    BIO MEDICA CORPORATION
(Exact name of registrant as specified
in its charter)
New
    York
0-28666
14-1702188
(State or other jurisdiction
of incorporation)
(Commission File
Number)
(IRS Employer
Identification Number)
122 Smith Road, Kinderhook, NY          
 12106
(Address of principal executive offices)
         (Zip Code)
Registrant's telephone number, including
area code: 518-758-8158
Not applicable
(Former name or former address, if changed
since last report.)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (
see
General Instruction
A.2. below):
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01          Entry
into a Material Definitive Agreement
On July 10, 2012, American
Bio Medica Corporation (the "Company") announced in a press release that it has entered into a Consent Decree with
the U.S. Food and Drug Administration ("FDA"). As of the date of this report, the Consent Decree still must be approved
by the United States District Court for the Northern District of New York.
Item 8.01
Other
Events
Risk Factor Disclosure
Pursuant to the disclosure provided under
Item 1.01, the Company is providing the following risk factor related to the Company's business:
Any adverse changes in our regulatory
framework could negatively impact our business, and we are currently operating under a Consent Decree with the U.S. Food and Drug
Administration (FDA) related to selling our OralStat product in workplace settings.
Our urine point of collection products
have received 510(k) marketing clearance from the FDA, and have therefore met FDA requirements for professional use. Our oral fluid
point of collection products have not received 510(k) marketing clearance from the FDA. We have also been granted a CLIA waiver
from the FDA related to our Rapid TOX product line. Workplace and Government are the Company's primary markets, and it has
been our belief (based on advice from FDA counsel) that marketing clearance from FDA is not required to sell our drug tests in
non-clinical (i.e. non-medical) markets (such as workplace and criminal justice/law enforcement), but is required to sell our products
in the clinical and over-the-counter (consumer) markets. We do not sell our oral fluid drug tests in clinical or over-the-counter
(consumer) markets. In addition, there are many other oral fluid point of collection drug tests currently being sold in the Workplace
market by our competitors, none of which have received FDA marketing clearance.
However, in July 2009, we received a warning
letter from the FDA, which alleges we are marketing our point of collection oral fluid drug test, OralStat, in workplace settings
without marketing clearance or approval (see Current Report on Form 8-K filed with the SEC on August 5, 2009).
The Company communicated to the FDA its
belief (based on legal opinion) that marketing clearance was not required in non-clinical markets. FDA continued to disagree with
the Company's interpretation of FDA regulations related to medical devices, and the FDA continued to assert jurisdiction
of drug testing performed in the workplace. The Company also advised FDA that it was willing to obtain marketing clearance but
that specific technical and scientific issues existed when attempting to utilize FDA's draft guidance for the Company's
OralStat (because the draft guidance was written for urine drug tests). Nevertheless, the Company and FDA were unable to reach
a consensus on neither the jurisdiction issue nor the technical issues.
On July 10, 2012 the Company announced
that it has entered into a Consent Decree with FDA. Under the terms of the Consent Decree, the Company will be allowed to continue
to market its OralStat drug test in the workplace market while it takes action to obtain a 510(k) marketing clearance. More specifically,
FDA will provide the Company with its most recent guidance on the clinical and analytical studies that need to be conducted to
gather data in support of a 510(k) submission for OralStat. The Company will then have a total of 396 days to discuss protocols
with FDA, complete its analytical and clinical studies and submit a substantially complete 510(k). The Company has agreed to withdraw
the OralStat product from the workplace market if any of the following events occur: 1) the Company does not submit a substantially
complete 510(k) within this specified time period, 2) the Company fails to submit additional information within time frames specified
by FDA, 3) the Company withdraws its submission, or 4) the Company's 510(k) submission results in FDA's determination
that the product is not substantially equivalent.
The cost of obtaining marketing clearance
is expected to be material and incurring such cost will have a negative impact on the Company's efforts to improve its performance
and to achieve profitability. Furthermore, there can be no assurance that we will obtain marketing clearance from the FDA and as
outlined in the Consent Decree, if we are unable to file our application within the time frame FDA requires, or if we are unable
to obtain marketing clearance for the OralStat, we will be forced to stop selling the OralStat product in the Workplace market.
Our point of collection oral fluid drug tests historically account for a material portion of our sales, with sales of oral fluid
drug tests accounting for approximately 20% of our sales in the last two completed fiscal years (the majority of which were sales
to the Workplace market). An inability to market and sell our point of collection oral fluid drug tests in the Workplace market
will negatively impact our revenues.
Although we are currently unaware of any
additional changes in regulatory standards related to any of our markets, if regulatory standards were to further change in the
future, there can be no assurance that the FDA will grant the Company appropriate marketing clearances required to comply with
the changes, if and when we apply for them. We will continue to take the necessary actions that will enable the Company to submit
a marketing clearance application to the FDA, and/or any additional actions that may be required to address the jurisdictional
question raised by our counsel.
Item 9.01
Financial Statements and Exhibits
(d)
Exhibits
Exhibit 99.1 Press Release dated July 10, 2012
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
AMERICAN BIO MEDICA CORPORATION (Registrant)
Dated: July 10, 2012
By:
/s/ Melissa A. Waterhouse
Melissa A. Waterhouse
EVP, Regulatory Affairs
Chief Compliance Officer
Corporate Secretary