K942958 is an FDA 510(k) clearance for the CREATINE KINASE MB DETERMINATION (UV). This device is classified as a U.v. Method, Cpk Isoenzymes (Class II - Special Controls, product code JHW).
Submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on November 21, 1994, 151 days after receiving the submission on June 23, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K942958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1994 |
| Decision Date | November 21, 1994 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JHW — U.v. Method, Cpk Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |