510(k) K112161 ยท KHO Fluorometer, For Clinical Use
AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..
| Applicant | Radiometer Medical Aps, Broenshoej, DK |
| Decision | Substantially Equivalent, Jan 20, 2012 |
| Received | Jul 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112161
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.