K071283 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS CREATININE REAGENT. This device is classified as a Alkaline Picrate, Colorimetry, Creatinine (Class II - Special Controls, product code CGX).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on June 1, 2007, 25 days after receiving the submission on May 7, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K071283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2007 |
| Decision Date | June 01, 2007 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGX — Alkaline Picrate, Colorimetry, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |