K051579 is an FDA 510(k) clearance for the IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on October 21, 2005, 129 days after receiving the submission on June 14, 2005.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K051579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2005 |
| Decision Date | October 21, 2005 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DKZ — Enzyme Immunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |