K253985
- 510(k) number
- K253985
- Device name
- INNOVANCE® D-Dimer 2.0 (SMN 10873803)
- Applicant
- Siemens Healthcare Diagnostic Products GmbH DE
- Product code
- DAP — Fibrinogen And Fibrin Split Products, Antigen, Antis
- Decision date
- 2026-08-11
- Date received
- 2025-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253985.pdf
Official FDA record: K253985
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.