K042476 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS VALP REAGENT. This device is classified as a Enzyme Immunoassay, Valproic Acid (Class II - Special Controls, product code LEG).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 1, 2004, 79 days after receiving the submission on September 13, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3645.
| 510(k) Number | K042476 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2004 |
| Decision Date | December 01, 2004 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LEG — Enzyme Immunoassay, Valproic Acid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3645 |