K964900 is an FDA 510(k) clearance for the RAPID DRUG SCREEN. This device is classified as a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II - Special Controls, product code DIO).
Submitted by American Bio Medica Corp. (Ancramdale, US). The FDA issued a Cleared decision on April 14, 1997, 138 days after receiving the submission on November 27, 1996.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K964900 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 1996 |
| Decision Date | April 14, 1997 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3250 |