Clearance Summary
CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 received FDA 510(k) clearance under submission number K050265, 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 2005-10-14.
- Submission: K050265
- Applicant / Sponsor: Chrono-Log Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5700
- Decision date: 2005-10-14
Classification & Regulation
This clearance is catalogued under FDA product code JOZ and 21 CFR 864.5700, within the Hematology review panel as a Class II device.