510(k) K810905 ยท JHW U.V. Method, Cpk Isoenzymes
ISOMUNE-CK
| Applicant | Hoffmann-La Roche, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 14, 1981 |
| Received | Apr 3, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810905
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.