K031924 is an FDA 510(k) clearance for the VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on August 7, 2003, 45 days after receiving the submission on June 23, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K031924 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2003 |
| Decision Date | August 07, 2003 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |