510(k) K861512 ยท JJT Enzyme Controls (Assayed And Unassayed)
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, May 23, 1986 |
| Received | Apr 23, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861512
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.