510(k) K041438 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
ADVANCED D-DIMER ASSAY
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 11, 2004 |
| Received | Jun 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2005 | Dade Behring , Inc. Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method. Terminated |
DAP | None listed |
| Feb 15, 2005 | Dade Behring , Inc. Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13. Terminated |
DAP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.