510(k) K984093 ยท MMI Immunoassay Method, Troponin Subunit
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Dec 14, 1998 |
| Received | Nov 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984093
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.