510(k) K162227 · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
STA® - Liatest® D-Di
| Applicant | Diagnostica Stago, Asnieres Sur Seine, FR |
| Decision | Substantially Equivalent, Dec 10, 2016 |
| Received | Aug 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162227
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2026 | Diagnostica Stago, Inc. Brand Name: STA Liatest D-Di
Product Name: STA Liatest D-Di
Model/Catalog Number: REF 00515
Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative det Open, Classified |
DAP | None listed |
| 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.