510(k) K993715 ยท JJT Enzyme Controls (Assayed And Unassayed)
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3
| Applicant | Seracare Technology, Austin TX, US |
| Decision | Substantially Equivalent, Nov 16, 1999 |
| Received | Nov 3, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993715
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.