K920507 is an FDA 510(k) clearance for the EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on February 27, 1992, 22 days after receiving the submission on February 5, 1992.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K920507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1992 |
| Decision Date | February 27, 1992 |
| Days to Decision | 22 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 |