K924429 is an FDA 510(k) clearance for the OPUS(R) CK-MB. This device is classified as a Colorimetric Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHY).
Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on October 15, 1992, 44 days after receiving the submission on September 1, 1992.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K924429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1992 |
| Decision Date | October 15, 1992 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | JHY — Colorimetric Method, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |