Clearance Summary
INNOVANCE® D-Dimer 2.0 (SMN 10873803) received FDA 510(k) clearance under submission number K253985, sponsored by Siemens Healthcare Diagnostic Products GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2026-08-11.
- Submission: K253985
- Applicant / Sponsor: Siemens Healthcare Diagnostic Products GmbH
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7320
- Decision date: 2026-08-11
Classification & Regulation
This clearance is catalogued under FDA product code DAP and 21 CFR 864.7320, within the Hematology review panel as a Class II device.