K012164 is an FDA 510(k) clearance for the 'RAPIDONE'-METHADONE TEST. This device is classified as a Enzyme Immunoassay, Methadone (Class II - Special Controls, product code DJR).
Submitted by American Bio Medica Corp. (Columbia, US). The FDA issued a Cleared decision on November 20, 2001, 132 days after receiving the submission on July 11, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3620.
| 510(k) Number | K012164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2001 |
| Decision Date | November 20, 2001 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJR — Enzyme Immunoassay, Methadone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3620 |