Clearance Summary
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II received FDA 510(k) clearance under submission number K865014, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1987-01-09.
- Submission: K865014
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5700
- Decision date: 1987-01-09
Classification & Regulation
This clearance is catalogued under FDA product code DGR and 21 CFR 866.5700, within the Immunology review panel as a Class I device.