K822933 is an FDA 510(k) clearance for the SYVA ADVANCE EMIT AED VALPROIC ACID ASSA. This device is classified as a Enzyme Immunoassay, Valproic Acid (Class II - Special Controls, product code LEG).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1982, 23 days after receiving the submission on October 4, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3645.
| 510(k) Number | K822933 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1982 |
| Decision Date | October 27, 1982 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LEG — Enzyme Immunoassay, Valproic Acid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3645 |