K962126 is an FDA 510(k) clearance for the ACS CKMB II IMMUNOASSAY. This device is classified as a Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHS).
Submitted by Ciba Corning Diagnostics Corp. (Irvine, US). The FDA issued a Cleared decision on June 21, 1996, 18 days after receiving the submission on June 3, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K962126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1996 |
| Decision Date | June 21, 1996 |
| Days to Decision | 18 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 |