K003158 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS CK-MB. This device is classified as a U.v. Method, Cpk Isoenzymes (Class II - Special Controls, product code JHW).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 18, 2000, 69 days after receiving the submission on October 10, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K003158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2000 |
| Decision Date | December 18, 2000 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHW — U.v. Method, Cpk Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |