FDA 510(k) Applications Submitted by AMERICAN BIO MEDICA CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K012159 06/22/2001 RAPID DRUG SCREEN AMERICAN BIO MEDICA CORP.
K041696 06/22/2004 RAPID READER AMERICAN BIO MEDICA CORP.
K053359 12/02/2005 RAPIDTOX AMERICAN BIO MEDICA CORP.
K030835 03/17/2003 'RAPID ONE' - PROPOXYPHENE TEST AMERICAN BIO MEDICA CORP.
K060760 03/21/2006 RAPIDONE-BUPRENORPHINE TEST AMERICAN BIO MEDICA CORP.
K021114 04/05/2002 'RAPIDTEC' 5A MULTIPLE DIP TEST AMERICAN BIO MEDICA CORP.
K041712 06/23/2004 'RAPIDTEC 4' TEST AMERICAN BIO MEDICA CORP.
K012164 07/11/2001 'RAPIDONE'-METHADONE TEST AMERICAN BIO MEDICA CORP.
K013180 09/24/2001 RAPIDONE-ECSTASY TEST AMERICAN BIO MEDICA CORP.
K993796 11/09/1999 RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE AMERICAN BIO MEDICA CORP.
K023869 11/20/2002 'RAPIDTEC'-5M-MULTIPLE DIP TEST AMERICAN BIO MEDICA CORP.
K993961 11/22/1999 RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) AMERICAN BIO MEDICA CORP.
K964900 11/27/1996 RAPID DRUG SCREEN AMERICAN BIO MEDICA CORP.
K053422 12/08/2005 RAPIDONE-COCAINE-150 TEST AMERICAN BIO MEDICA CORP.
K014101 12/13/2001 RAPIDONE-OXY TEST AMERICAN BIO MEDICA CORP.
K984525 12/21/1998 RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST AMERICAN BIO MEDICA CORP.
K980872 03/06/1998 RAPID DRUG SCREEN' 8 PANEL AMERICAN BIO MEDICA CORP.
K990818 03/11/1999 RAPIDONE - MARIJUANA TEST AMERICAN BIO MEDICA CORP.
K990820 03/11/1999 RAPIDONE - OPIATES TEST AMERICAN BIO MEDICA CORP.
K990822 03/11/1999 RAPIDONE - COCAINE TEST AMERICAN BIO MEDICA CORP.
K981705 05/14/1998 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME AMERICAN BIO MEDICA CORP.
K992033 06/16/1999 MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL AMERICAN BIO MEDICA CORP.
K992451 07/22/1999 RAPIDONE- BARBITURATE TEST AMERICAN BIO MEDICA CORP.
K992452 07/22/1999 RAPIDONE-AMPHETAMINE TEST AMERICAN BIO MEDICA CORP.
K002447 08/09/2000 MODIFICATION TO RAPID DRUG SCREEN 9-PANEL AMERICAN BIO MEDICA CORP.
K992720 08/13/1999 RAPIDONE- BENZODIAZEPINE TEST AMERICAN BIO MEDICA CORP.
K993151 09/21/1999 RADID DRUG SCREEN 5-PANEL TEST AMERICAN BIO MEDICA CORP.
K983770 10/26/1998 'RAPID DRUG SCREEN' 9-PANEL AMERICAN BIO MEDICA CORP.
K170222 01/25/2017 Rapid Tox Cup II AMERICAN BIO MEDICA CORP.
K073078 10/31/2007 RAPID TOX CUP AMERICAN BIO MEDICA CORP.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact