510(k) K182702 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
SEKURE Creatine Kinase Assay
| Applicant | Sekisui Diagnostics P.E.I., Inc., Charlottetown,, CA |
| Decision | Substantially Equivalent, Apr 17, 2019 |
| Received | Sep 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182702
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.