Clearance Summary
PLATELET AGGREGATION REAGENT received FDA 510(k) clearance under submission number K850592, 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 1985-05-13.
- Submission: K850592
- Applicant / Sponsor: Chrono-Log Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6675
- Decision date: 1985-05-13
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.