Clearance Summary
vWF Ag received FDA 510(k) clearance under submission number K220728, sponsored by Siemens Healthcare Diagnostics 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 2023-06-02.
- Submission: K220728
- Applicant / Sponsor: Siemens Healthcare Diagnostics Products GmbH
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7290
- Decision date: 2023-06-02
Classification & Regulation
This clearance is catalogued under FDA product code GGP and 21 CFR 864.7290, within the Hematology review panel as a Class II device.