K060690 is an FDA 510(k) clearance for the ONLINE 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 8, 2006, 146 days after receiving the submission on March 15, 2006.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3645.
| 510(k) Number | K060690 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2006 |
| Decision Date | August 08, 2006 |
| Days to Decision | 146 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 |