510(k) K991176 ยท JIT Calibrator, Secondary
OPUS TROPONIN I CALIBRATOR
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 1, 1999 |
| Received | Apr 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991176
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.