Clearance Summary
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 received FDA 510(k) clearance under submission number K032611, sponsored by Bio-Rad. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2003-09-17.
- Submission: K032611
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 2003-09-17
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.