K022682 is an FDA 510(k) clearance for the RANDOX C-REACTIVE PROTEIN CALIBRATOR. This device is classified as a Calibrator, Primary (Class II - Special Controls, product code JIS).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on November 5, 2002, 85 days after receiving the submission on August 12, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K022682 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2002 |
| Decision Date | November 05, 2002 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JIS — Calibrator, Primary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |