K951223 is an FDA 510(k) clearance for the CK-MB (NAC-ACT). This device is classified as a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II - Special Controls, product code CGS).
Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on December 26, 1995, 281 days after receiving the submission on March 20, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K951223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1995 |
| Decision Date | December 26, 1995 |
| Days to Decision | 281 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 |