Clearance Summary
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV received FDA 510(k) clearance under submission number K091303, 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 2010-08-02.
- Submission: K091303
- Applicant / Sponsor: Bio-Rad Laboratories
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8625
- Decision date: 2010-08-02
Classification & Regulation
This clearance is catalogued under FDA product code JPK and 21 CFR 864.8625, within the Hematology review panel as a Class II device.