510(k) K980528 ยท MMI Immunoassay Method, Troponin Subunit
CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
| Applicant | Chiron Diagnostics Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Mar 3, 1998 |
| Received | Feb 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980528
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.