K913298 is an FDA 510(k) clearance for the AIA-PACK CK-MB. This device is classified as a Fluorometric Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHX).
Submitted by Tosoh Corp. (Washington, D.C., US). The FDA issued a Cleared decision on September 27, 1991, 64 days after receiving the submission on July 25, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K913298 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1991 |
| Decision Date | September 27, 1991 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JHX — Fluorometric Method, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |