K830672 is an FDA 510(k) clearance for the CREATINE KINASE REAGENT SET. This device is classified as a Colorimetric Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHY).
Submitted by Sterling Biochemical, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983, 32 days after receiving the submission on March 4, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K830672 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1983 |
| Decision Date | April 05, 1983 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JHY — Colorimetric Method, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |