K884550 is an FDA 510(k) clearance for the CREATINE KINASE MB ENZYME IMMUNOASSAY KIT. This device is classified as a Colorimetric Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHY).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 23, 1989, 115 days after receiving the submission on October 31, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K884550 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 1988 |
| Decision Date | February 23, 1989 |
| Days to Decision | 115 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 |