K820812 is an FDA 510(k) clearance for the CREATINE KINASE-MB KIT. This device is classified as a Colorimetric Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHY).
Submitted by Calbiochem-Behring Corp. (Walker, US). The FDA issued a Cleared decision on April 12, 1982, 20 days after receiving the submission on March 23, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K820812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1982 |
| Decision Date | April 12, 1982 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JHY — Colorimetric Method, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |