K900806 is an FDA 510(k) clearance for the STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY. This device is classified as a Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHS).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on March 23, 1990, 30 days after receiving the submission on February 21, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K900806 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1990 |
| Decision Date | March 23, 1990 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |