510(k) K935566 ยท LIE Reagent/Device, Inoculum Calibration
SENSI-CAL AMCO AEPA-1
| Applicant | Radiometer America, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, Mar 29, 1994 |
| Received | Nov 18, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935566
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.