510(k) K163462 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
| Applicant | Radiometer Medical Aps, Dk-Bronshoj, DK |
| Decision | Substantially Equivalent, Sep 21, 2017 |
| Received | Dec 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163462
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.