K823741 is an FDA 510(k) clearance for the ADVANCE EMIT-AED PRIMEDONE ASSAY. This device is classified as a Fluorescent Immunoassay, Primidone (Class II - Special Controls, product code LFT).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983, 25 days after receiving the submission on December 13, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3680.
| 510(k) Number | K823741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1982 |
| Decision Date | January 07, 1983 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LFT — Fluorescent Immunoassay, Primidone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3680 |