American Bio Medica Corp.
Washington, DC, US
American Bio Medica Corp. appears in FDA device records in Washington, DC. FDA records list 30 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 30
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 30 510(k) clearances for American Bio Medica Corp. between 1997 and 2017. The busiest year on record is 1999, with 7. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 3 |
| 1999 | 7 |
| 2000 | 5 |
| 2001 | 3 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 3 |
| 2008 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170222 | Rapid Tox Cup II | LAF | Substantially Equivalent | |
| K073078 | RAPID TOX CUP | LAG | Substantially Equivalent | |
| K060760 | RAPIDONE-BUPRENORPHINE TEST | DJG | Substantially Equivalent | |
| K053422 | RAPIDONE-COCAINE-150 TEST | DIO | Substantially Equivalent | |
| K053359 | RAPIDTOX | DKZ | Substantially Equivalent | |
| K041696 | RAPID READER | DKZ | Substantially Equivalent | |
| K041712 | 'RAPIDTEC 4' TEST | DIS | Substantially Equivalent | |
| K030835 | 'RAPID ONE' - PROPOXYPHENE TEST | JXN | Substantially Equivalent | |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE DIP TEST | DJR | Substantially Equivalent | |
| K021114 | 'RAPIDTEC' 5A MULTIPLE DIP TEST | DKZ | Substantially Equivalent | |
| K014101 | RAPIDONE-OXY TEST | DJG | Substantially Equivalent | |
| K013180 | RAPIDONE-ECSTASY TEST | DJC | Substantially Equivalent | |
| K012164 | 'RAPIDONE'-METHADONE TEST | DJR | Substantially Equivalent | |
| K012159 | RAPID DRUG SCREEN | DKZ | Substantially Equivalent | |
| K002447 | MODIFICATION TO RAPID DRUG SCREEN 9-PANEL | DKZ | Substantially Equivalent | |
| K992720 | RAPIDONE- BENZODIAZEPINE TEST | JXM | Substantially Equivalent | |
| K992451 | RAPIDONE- BARBITURATE TEST | DIS | Substantially Equivalent | |
| K993961 | RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) | LDJ | Substantially Equivalent | |
| K993151 | RADID DRUG SCREEN 5-PANEL TEST | DJG | Substantially Equivalent | |
| K993796 | RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE | LDJ | Substantially Equivalent | |
| K992452 | RAPIDONE-AMPHETAMINE TEST | DOD | Substantially Equivalent | |
| K990822 | RAPIDONE - COCAINE TEST | DIO | Substantially Equivalent | |
| K990820 | RAPIDONE - OPIATES TEST | DJG | Substantially Equivalent | |
| K990818 | RAPIDONE - MARIJUANA TEST | LDJ | Substantially Equivalent | |
| K992033 | MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL | DKZ | Substantially Equivalent | |
| K984525 | RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST | DKZ | Substantially Equivalent | |
| K983770 | 'RAPID DRUG SCREEN' 9-PANEL | DKZ | Substantially Equivalent | |
| K981705 | 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME | DKZ | Substantially Equivalent | |
| K980872 | RAPID DRUG SCREEN' 8 PANEL | DIO | Substantially Equivalent | |
| K964900 | RAPID DRUG SCREEN | DIO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- JXNEnzyme Immunoassay, Propoxyphene
- DODGas Chromatography, Amphetamine
- LAFGas Chromatography, Methamphetamine
- LAGHigh Pressure Liquid Chromatography, Methamphetamine
- DJCThin Layer Chromatography, Methamphetamine
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain