510(k) K191296 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Pointe Scientific Creatinine Kinase (CK) Reagent Set
| Applicant | Medtest DX, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Aug 11, 2020 |
| Received | May 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191296
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.