K060935 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS CREATININE (CREA) 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 April 28, 2006, 23 days after receiving the submission on April 5, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K060935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2006 |
| Decision Date | April 28, 2006 |
| Days to Decision | 23 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 |