K053359 is an FDA 510(k) clearance for the RAPIDTOX. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by American Bio Medica Corp. (Beverly, US). The FDA issued a Cleared decision on May 25, 2006, 174 days after receiving the submission on December 2, 2005.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K053359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2005 |
| Decision Date | May 25, 2006 |
| Days to Decision | 174 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |