510(k) K033487 ยท MMI Immunoassay Method, Troponin Subunit
STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
| Applicant | Dade Behring, Inc., Newark, DE, US |
| Decision | Substantially Equivalent, Dec 24, 2003 |
| Received | Nov 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033487
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI) 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.