510(k) K051597 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
STRATUS CS D-DIMER
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 17, 2005 |
| Received | Jun 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051597
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer DDMR TestPak (CDDMR) 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.