Company ยท US
American Bio Medica Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2017. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 9 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 4 |
| DJG | Enzyme Immunoassay, Opiates | 4 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 |
| DJR | Enzyme Immunoassay, Methadone | 2 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 |
| DOD | Gas Chromatography, Amphetamine | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 |
| JXN | Enzyme Immunoassay, Propoxyphene | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 |
| LAG | High Pressure Liquid Chromatography, Methamphetamine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 15, 2017 | K170222 | Rapid Tox Cup II American Bio Medica Corp. | LAF |
| May 30, 2008 | K073078 | RAPID TOX CUP American Bio Medica Corp. | LAG |
| Aug 7, 2006 | K060760 | RAPIDONE-BUPRENORPHINE TEST American Bio Medica Corp. | DJG |
| Jun 15, 2006 | K053422 | RAPIDONE-COCAINE-150 TEST American Bio Medica Corp. | DIO |
| May 25, 2006 | K053359 | RAPIDTOX American Bio Medica Corp. | DKZ |
| Jul 12, 2005 | K041696 | RAPID READER American Bio Medica Corp. | DKZ |
| Nov 3, 2004 | K041712 | 'RAPIDTEC 4' TEST American Bio Medica Corp. | DIS |
| May 22, 2003 | K030835 | 'RAPID ONE' - PROPOXYPHENE TEST American Bio Medica Corp. | JXN |
| Apr 30, 2003 | K023869 | 'RAPIDTEC'-5M-MULTIPLE DIP TEST American Bio Medica Corp. | DJR |
| Jul 23, 2002 | K021114 | 'RAPIDTEC' 5A MULTIPLE DIP TEST American Bio Medica Corp. | DKZ |
| Mar 20, 2002 | K014101 | RAPIDONE-OXY TEST American Bio Medica Corp. | DJG |
| Nov 26, 2001 | K013180 | RAPIDONE-ECSTASY TEST American Bio Medica Corp. | DJC |
| Nov 20, 2001 | K012164 | 'RAPIDONE'-METHADONE TEST American Bio Medica Corp. | DJR |
| Jul 25, 2001 | K012159 | RAPID DRUG SCREEN American Bio Medica Corp. | DKZ |
| Nov 16, 2000 | K002447 | MODIFICATION TO RAPID DRUG SCREEN 9-PANEL American Bio Medica Corp. | DKZ |
| Apr 3, 2000 | K992720 | RAPIDONE- BENZODIAZEPINE TEST American Bio Medica Corp. | JXM |
| Apr 3, 2000 | K992451 | RAPIDONE- BARBITURATE TEST American Bio Medica Corp. | DIS |
| Jan 24, 2000 | K993961 | RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) American Bio Medica Corp. | LDJ |
| Jan 10, 2000 | K993151 | RADID DRUG SCREEN 5-PANEL TEST American Bio Medica Corp. | DJG |
| Dec 21, 1999 | K993796 | RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE American Bio Medica Corp. | LDJ |
| Oct 18, 1999 | K992452 | RAPIDONE-AMPHETAMINE TEST American Bio Medica Corp. | DOD |
| Jul 15, 1999 | K990822 | RAPIDONE - COCAINE TEST American Bio Medica Corp. | DIO |
| Jul 15, 1999 | K990820 | RAPIDONE - OPIATES TEST American Bio Medica Corp. | DJG |
| Jul 7, 1999 | K990818 | RAPIDONE - MARIJUANA TEST American Bio Medica Corp. | LDJ |
| Jun 30, 1999 | K992033 | MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL American Bio Medica Corp. | DKZ |
| Feb 26, 1999 | K984525 | RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST American Bio Medica Corp. | DKZ |
| Dec 31, 1998 | K983770 | 'RAPID DRUG SCREEN' 9-PANEL American Bio Medica Corp. | DKZ |
| Aug 27, 1998 | K981705 | 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME American Bio Medica Corp. | DKZ |
| Mar 20, 1998 | K980872 | RAPID DRUG SCREEN' 8 PANEL American Bio Medica Corp. | DIO |
| Apr 14, 1997 | K964900 | RAPID DRUG SCREEN American Bio Medica Corp. | DIO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||