K803236 is an FDA 510(k) clearance for the CYBREX VALPROIC ACID. This device is classified as a Enzyme Immunoassay, Valproic Acid (Class II - Special Controls, product code LEG).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 28, 1981, 36 days after receiving the submission on December 23, 1980.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3645.
| 510(k) Number | K803236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1980 |
| Decision Date | January 28, 1981 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LEG — Enzyme Immunoassay, Valproic Acid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3645 |