510(k) K974596 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
DIMERTEST LATEX ASSAY
| Applicant | Agen Biomedical , Ltd., Brisbane 4110, AU |
| Decision | Substantially Equivalent, May 26, 1998 |
| Received | Dec 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974596
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.