FDA.reportPublic FDA data

AMERICAN BIO MEDICA CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13207383000718556AMERICAN BIO MEDICA CORP.1N2020-04-25122 Smith Rd KINDERHOOK NY US 12106
22497813003204823AMERICAN BIO MEDICA CORP.1N2020-04-25603 Heron Dr Ste 4 Swedesboro NJ US 08085

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
165401949795622K993961RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)LDJ2000-01-24
165391949795622K993961RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)LDJ2000-01-24
165391851623529K993796RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINELDJ1999-12-21
165401851623529K993796RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINELDJ1999-12-21
165391846508040K993151RADID DRUG SCREEN 5-PANEL TESTDJG2000-01-10
165401846508040K993151RADID DRUG SCREEN 5-PANEL TESTDJG2000-01-10
165391328041957K992451RAPIDONE- BARBITURATE TESTDIS2000-04-03
165401328041957K992451RAPIDONE- BARBITURATE TESTDIS2000-04-03
165391425457706K990820RAPIDONE - OPIATES TESTDJG1999-07-15
165401425457706K990820RAPIDONE - OPIATES TESTDJG1999-07-15
165391790875396K990818RAPIDONE - MARIJUANA TESTLDJ1999-07-07
165401790875396K990818RAPIDONE - MARIJUANA TESTLDJ1999-07-07
165391555166111K984525RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TESTDKZ1999-02-26
165401555166111K984525RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TESTDKZ1999-02-26
165391550046418K983770'RAPID DRUG SCREEN' 9-PANELDKZ1998-12-31
165401550046418K983770'RAPID DRUG SCREEN' 9-PANELDKZ1998-12-31
165401071891943K981705'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUMEDKZ1998-08-27
165391071891943K981705'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUMEDKZ1998-08-27
165401934272795K980872RAPID DRUG SCREEN' 8 PANELDIO1998-03-20
165391934272795K980872RAPID DRUG SCREEN' 8 PANELDIO1998-03-20
165392018557984K170222Rapid Tox Cup IILAF2017-08-15
165402018557984K170222Rapid Tox Cup IILAF2017-08-15
165401743818585K073078RAPID TOX CUPLAG2008-05-30
165401412833989K060760RAPIDONE-BUPRENORPHINE TESTDJG2006-08-07
165391412833989K060760RAPIDONE-BUPRENORPHINE TESTDJG2006-08-07
165401226084896K053422RAPIDONE-COCAINE-150 TESTDIO2006-06-15
165391226084896K053422RAPIDONE-COCAINE-150 TESTDIO2006-06-15
165391186578619K053359RAPIDTOXDKZ2006-05-25
165401186578619K053359RAPIDTOXDKZ2006-05-25
165401089732487K041712'RAPIDTEC 4' TESTDIS2004-11-03
165391089732487K041712'RAPIDTEC 4' TESTDIS2004-11-03
165401221623559K041696RAPID READERDKZ2005-07-12
165391221623559K041696RAPID READERDKZ2005-07-12
165402073352514K030835'RAPID ONE' - PROPOXYPHENE TESTJXN2003-05-22
165392073352514K030835'RAPID ONE' - PROPOXYPHENE TESTJXN2003-05-22
165401984108067K021789QUICKLAB RSVGQG2002-11-20
165391772389860K021114'RAPIDTEC' 5A MULTIPLE DIP TESTDKZ2002-07-23
165401772389860K021114'RAPIDTEC' 5A MULTIPLE DIP TESTDKZ2002-07-23
165391824991208K014101RAPIDONE-OXY TESTDJG2002-03-20
165401824991208K014101RAPIDONE-OXY TESTDJG2002-03-20
165391187339264K012159RAPID DRUG SCREENDKZ2001-07-25
165401187339264K012159RAPID DRUG SCREENDKZ2001-07-25
165401729546289K002447MODIFICATION TO RAPID DRUG SCREEN 9-PANELDKZ2000-11-16
165391729546289K002447MODIFICATION TO RAPID DRUG SCREEN 9-PANELDKZ2000-11-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DKZ162006-05-25
DJG82006-08-07
LDJ62000-01-24
DIO42006-06-15
DIS42004-11-03
LAF22017-08-15
JXN22003-05-22
LAG12008-05-30
GQG12002-11-20

PMN#