Clearance Summary
AGGREGOMETER, DUAL CHANNEL PLATELET received FDA 510(k) clearance under submission number K760159, sponsored by Chrono-Log 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 1976-07-20.
- Submission: K760159
- Applicant / Sponsor: Chrono-Log Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6675
- Decision date: 1976-07-20
Classification & Regulation
This clearance is catalogued under FDA product code JBX and 21 CFR 864.6675, within the Hematology review panel as a Class II device.