510(k) K905623 ยท JJT Enzyme Controls (Assayed And Unassayed)
CK-MB IMMUNOASSAY CONTROL
| Applicant | Seradyn, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 22, 1991 |
| Received | Dec 14, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905623
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.