510(k) K931050 ยท JHW U.V. Method, Cpk Isoenzymes
CARDIO REP CK ISOENZYME KIT - 3310
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Apr 20, 1993 |
| Received | Mar 1, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931050
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.