K930873 is an FDA 510(k) clearance for the CKMB ISOENZYME CONTROL-LEVEL 1,2.3. This device is classified as a Enzyme Controls (assayed And Unassayed) (Class I - General Controls, product code JJT).
Submitted by Cala Diagnostics (Los Osos, US). The FDA issued a Cleared decision on April 13, 1993, 53 days after receiving the submission on February 19, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K930873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1993 |
| Decision Date | April 13, 1993 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JJT — Enzyme Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |