K032049 is an FDA 510(k) clearance for the ROCHE ONLINE TDM VALPROIC ACID. This device is classified as a Enzyme Immunoassay, Valproic Acid (Class II - Special Controls, product code LEG).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 22, 2003, 51 days after receiving the submission on July 2, 2003.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3645.
| 510(k) Number | K032049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2003 |
| Decision Date | August 22, 2003 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LEG — Enzyme Immunoassay, Valproic Acid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3645 |