510(k) K981098 ยท MMI Immunoassay Method, Troponin Subunit
STRATUS CS CARDIAC TROPONIN I TESTPAK
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 27, 1998 |
| Received | Mar 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981098
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer cTnI DilPak (CCTNI-D) in vitro diagnostic. Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.