510(k) K022976 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 16, 2003 |
| Received | Sep 6, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022976
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer DDMR DilPak (CDDMR-D) in vitro diagnostic. Terminated |
DAP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.