The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for Rapid Drug Screen 3-panel Test For Cocaine, Marijuana (thc) (cannabinoids) And Opiates (3 Panel Test For Cto).
| Device ID | K993961 |
| 510k Number | K993961 |
| Device Name: | RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | AMERICAN BIO MEDICA CORP. 122 SMITH RD. Kinderhook, NY 12106 |
| Contact | Henry Wells |
| Correspondent | Henry Wells AMERICAN BIO MEDICA CORP. 122 SMITH RD. Kinderhook, NY 12106 |
| Product Code | LDJ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-22 |
| Decision Date | 2000-01-24 |
| Summary: | summary |