K945083 is an FDA 510(k) clearance for the ACCESS CK-MB REAGENTS. This device is classified as a Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHS).
Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on November 21, 1994, 35 days after receiving the submission on October 17, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K945083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 1994 |
| Decision Date | November 21, 1994 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |