510(k) K112818 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
VIDAS D-DIMER EXCLUSION II (DEX2)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jul 31, 2012 |
| Received | Sep 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112818
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2014 | BioMerieux SA VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enz Terminated |
DAP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.