K090358 is an FDA 510(k) clearance for the ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35. This device is classified as a Enzyme Immunoassay, Valproic Acid (Class II - Special Controls, product code LEG).
Submitted by Abbott Laboratories, Inc. (Abbott Park, US). The FDA issued a Cleared decision on August 6, 2009, 175 days after receiving the submission on February 12, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3645.
| 510(k) Number | K090358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2009 |
| Decision Date | August 06, 2009 |
| Days to Decision | 175 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 |