K884085 is an FDA 510(k) clearance for the TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY. This device is classified as a Colorimetric Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHY).
Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 2, 1988, 66 days after receiving the submission on September 27, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K884085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1988 |
| Decision Date | December 02, 1988 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JHY — Colorimetric Method, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |