510(k) K912231 ยท JHW U.V. Method, Cpk Isoenzymes
PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT
| Applicant | Intl. Immunoassay Laboratories, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jul 8, 1991 |
| Received | May 20, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912231
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.