510(k) K905643 ยท GHH Fibrin Split Products
BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
| Applicant | Agen Biomedical , Ltd., Brisbane, AU |
| Decision | Substantially Equivalent, Apr 12, 1991 |
| Received | Dec 17, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905643
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2016 | BBI SOLUTIONS OEM LTD SimpliRED D-Dimer, Product Code DSRK4
The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in Terminated |
GHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.