Clearance Summary
THROMBO-SCREEN PLATELET ADHESION received FDA 510(k) clearance under submission number K771678, sponsored by Bay Area Hema. Onco. Clinic. & Res. L. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1977-11-22.
- Submission: K771678
- Applicant / Sponsor: Bay Area Hema. Onco. Clinic. & Res. L
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6650
- Decision date: 1977-11-22
Classification & Regulation
This clearance is catalogued under FDA product code JBZ and 21 CFR 864.6650, within the Hematology review panel as a Class II device.