K023869 is an FDA 510(k) clearance for the 'RAPIDTEC'-5M-MULTIPLE DIP 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 April 30, 2003, 161 days after receiving the submission on November 20, 2002.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3620.
| 510(k) Number | K023869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2002 |
| Decision Date | April 30, 2003 |
| Days to Decision | 161 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 |