Clearance Summary
KIT, PLATELET AGGREGATION REAGENT (#390) received FDA 510(k) clearance under submission number K760198, 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 1976-07-19.
- Submission: K760198
- Applicant / Sponsor: Chrono-Log Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5700
- Decision date: 1976-07-19
Classification & Regulation
This clearance is catalogued under FDA product code GHR and 21 CFR 864.5700, within the Hematology review panel as a Class II device.