Clearance Summary
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 received FDA 510(k) clearance under submission number K052838, 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 2005-11-09.
- Submission: K052838
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8625
- Decision date: 2005-11-09
Classification & Regulation
This clearance is catalogued under FDA product code GGM and 21 CFR 864.8625, within the Hematology review panel as a Class II device.