K051648 is an FDA 510(k) clearance for the SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS. This device is classified as a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II - Special Controls, product code CGS).
Submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on January 31, 2006, 224 days after receiving the submission on June 21, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K051648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2005 |
| Decision Date | January 31, 2006 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGS - Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |