K962549 is an FDA 510(k) clearance for the VIDAS CREATINE KINASE MB ASSAY 30-421. This device is classified as a Fluorometric Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHX).
Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on August 30, 1996, 63 days after receiving the submission on June 28, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K962549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 1996 |
| Decision Date | August 30, 1996 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHX — Fluorometric Method, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |