510(k) K903508 ยท JHW U.V. Method, Cpk Isoenzymes
LABELLING CHANGES TO IMPRES-MB-X
| Applicant | Intl. Immunoassay Laboratories, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Sep 7, 1990 |
| Received | Jul 31, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903508
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.