K040976 is an FDA 510(k) clearance for the GENCHEM CREATININE REAGENT. This device is classified as a Alkaline Picrate, Colorimetry, Creatinine (Class II - Special Controls, product code CGX).
Submitted by Genchem, Inc. (Brea, US). The FDA issued a Cleared decision on December 27, 2004, 257 days after receiving the submission on April 14, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K040976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2004 |
| Decision Date | December 27, 2004 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| 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 |