K021114 is an FDA 510(k) clearance for the 'RAPIDTEC' 5A MULTIPLE DIP TEST. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by American Bio Medica Corp. (Columbia, US). The FDA issued a Cleared decision on July 23, 2002, 109 days after receiving the submission on April 5, 2002.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K021114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2002 |
| Decision Date | July 23, 2002 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |