Clearance Summary
LIQUICHEK RHEUMATOID FACTOR CONTROL received FDA 510(k) clearance under submission number K960987, 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 1996-06-04.
- Submission: K960987
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 1996-06-04
Classification & Regulation
This clearance is catalogued under FDA product code DHR and 21 CFR 866.5775, within the Immunology review panel as a Class II device.