American Bio Medica Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 30
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K170222 | Rapid Tox Cup II | August 15, 2017 |
| K073078 | RAPID TOX CUP | May 30, 2008 |
| K060760 | RAPIDONE-BUPRENORPHINE TEST | August 7, 2006 |
| K053422 | RAPIDONE-COCAINE-150 TEST | June 15, 2006 |
| K053359 | RAPIDTOX | May 25, 2006 |
| K041696 | RAPID READER | July 12, 2005 |
| K041712 | 'RAPIDTEC 4' TEST | November 3, 2004 |
| K030835 | 'RAPID ONE' - PROPOXYPHENE TEST | May 22, 2003 |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE DIP TEST | April 30, 2003 |
| K021114 | 'RAPIDTEC' 5A MULTIPLE DIP TEST | July 23, 2002 |
| K014101 | RAPIDONE-OXY TEST | March 20, 2002 |
| K013180 | RAPIDONE-ECSTASY TEST | November 26, 2001 |
| K012164 | 'RAPIDONE'-METHADONE TEST | November 20, 2001 |
| K012159 | RAPID DRUG SCREEN | July 25, 2001 |
| K002447 | MODIFICATION TO RAPID DRUG SCREEN 9-PANEL | November 16, 2000 |
| K992451 | RAPIDONE- BARBITURATE TEST | April 3, 2000 |
| K992720 | RAPIDONE- BENZODIAZEPINE TEST | April 3, 2000 |
| K993961 | RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST | January 24, 2000 |
| K993151 | RADID DRUG SCREEN 5-PANEL TEST | January 10, 2000 |
| K993796 | RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHA | December 21, 1999 |