Clearance Summary
LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH received FDA 510(k) clearance under submission number K942209, 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 1994-06-16.
- Submission: K942209
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8625
- Decision date: 1994-06-16
Classification & Regulation
This clearance is catalogued under FDA product code JCN and 21 CFR 864.8625, within the Hematology review panel as a Class II device.