510(k) K930889 ยท JJT Enzyme Controls (Assayed And Unassayed)
ROCHE CARDIOTROL-CK
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jul 6, 1993 |
| Received | Feb 22, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930889
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.