Clearance Summary
R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) received FDA 510(k) clearance under submission number K961610, sponsored by R&D Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1996-07-01.
- Submission: K961610
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 1996-07-01
Classification & Regulation
This clearance is catalogued under FDA product code GKZ and 21 CFR 864.5220, within the Hematology review panel as a Class II device.