K182702 is an FDA 510(k) clearance for the SEKURE Creatine Kinase Assay. This device is classified as a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II - Special Controls, product code CGS).
Submitted by Sekisui Diagnostics P.E.I., Inc. (Charlottetown,, CA). The FDA issued a Cleared decision on April 17, 2019, 202 days after receiving the submission on September 27, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K182702 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2018 |
| Decision Date | April 17, 2019 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGS - Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |