510(k) K983693 ยท JIT Calibrator, Secondary
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Nov 4, 1998 |
| Received | Oct 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983693
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.