K062460 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 15, 2006, 114 days after receiving the submission on August 23, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K062460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2006 |
| Decision Date | December 15, 2006 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |