Clearance Summary
LYPHOCHEK COAGULATION CONTROL received FDA 510(k) clearance under submission number K964963, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1997-02-20.
- Submission: K964963
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 1997-02-20
Classification & Regulation
This clearance is catalogued under FDA product code GGN and 21 CFR 864.5425, within the Hematology review panel as a Class II device.