510(k) K012233 ยท JIT Calibrator, Secondary
STRATUS CS TROPONIN I CALIBRATOR
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Sep 11, 2001 |
| Received | Jul 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012233
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.