510(k) K253985 · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
INNOVANCE® D-Dimer 2.0 (SMN 10873803)
| Applicant | Siemens Healthcare Diagnostic Products GmbH, Marburg, DE |
| Decision | Substantially Equivalent, Aug 11, 2026 |
| Received | Dec 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253985
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.