Clearance Summary
VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA received FDA 510(k) clearance under submission number K860751, sponsored by Bio/Data Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1986-03-18.
- Submission: K860751
- Applicant / Sponsor: Bio/Data Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8625
- Decision date: 1986-03-18
Classification & Regulation
This clearance is catalogued under FDA product code JPK and 21 CFR 864.8625, within the Hematology review panel as a Class II device.