Submission Details
| 510(k) Number | K042476 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS
Dec 2004
Decision
79d
Days
Class 2
Risk
About This 510(k) Submission
K042476 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS, 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 review panel. Regulated under 21 CFR 862.3645.
Device Classification
| Product Code | LEG — Enzyme Immunoassay, Valproic Acid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3645 |
Manufacturer
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