Clearance Summary
LYPHOCHEK DIABETES CONTROL received FDA 510(k) clearance under submission number K070546, sponsored by Bio-Rad Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2007-04-02.
- Submission: K070546
- Applicant / Sponsor: Bio-Rad Laboratories
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8625
- Decision date: 2007-04-02
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.