510(k) K964728 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
STA-LIATEST D-DI TEST KIT
| Applicant | American Bioproducts Co., Parisppany NJ, US |
| Decision | Substantially Equivalent, Jun 26, 1997 |
| Received | Nov 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964728
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2025 | Diagnostica Stago, Inc. Product: STA Liatest D-Di;
REF: 00515; Open, Classified |
DAP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.