510(k) K141265 ยท JHW U.V. Method, Cpk Isoenzymes
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
| Applicant | Elitechgroup, Bothell WA, US |
| Decision | Substantially Equivalent, Jul 18, 2014 |
| Received | May 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141265
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.