510(k) K043476 ยท NBC Test, Natriuretic Peptide
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Feb 15, 2005 |
| Received | Dec 16, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043476
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer Acute Care pBNP TestPak (CpBNP) in vitro diagnostic. Terminated |
NBC | None listed |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer Acute Care pBNP DilPak (CpBNP-D) in vitro diagnostic. Terminated |
NBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.