K062285 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV. This device is classified as a Enzyme Immunoassay, Benzodiazepine (Class II - Special Controls, product code JXM).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 22, 2006, 137 days after receiving the submission on August 7, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3170.
| 510(k) Number | K062285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2006 |
| Decision Date | December 22, 2006 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JXM — Enzyme Immunoassay, Benzodiazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3170 |