K053422 is an FDA 510(k) clearance for the RAPIDONE-COCAINE-150 TEST. 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. (Columbia, US). The FDA issued a Cleared decision on June 15, 2006, 189 days after receiving the submission on December 8, 2005.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3250.
| 510(k) Number | K053422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2005 |
| Decision Date | June 15, 2006 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3250 |