510(k) K120326 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
| Applicant | Radiometer Medical Aps, Bronshoj, DK |
| Decision | Substantially Equivalent, Nov 21, 2012 |
| Received | Feb 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120326
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.