510(k) K260214 · KFF Assay, Heparin
STA® - Liquid Anti-Xa
| Applicant | Diagnostica Stago, Inc., Parsippany NJ, US |
| Decision | Substantially Equivalent, Sep 24, 2026 |
| Received | Jan 23, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260214
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.