510(k) K913380 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
MYDAS(TM)-MB2/MYDAS(TM)-MB
| Applicant | Intl. Immunoassay Laboratories, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Apr 22, 1992 |
| Received | Jul 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913380
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.