Clearance Summary
WHOLE BLOOD PLATELET COUNTER -2510 received FDA 510(k) clearance under submission number K760765, sponsored by Clay Adams, Div. Becton Dickinson & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1976-12-30.
- Submission: K760765
- Applicant / Sponsor: Clay Adams, Div. Becton Dickinson & Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5200
- Decision date: 1976-12-30
Classification & Regulation
This clearance is catalogued under FDA product code GKL and 21 CFR 864.5200, within the Hematology review panel as a Class II device.