Clearance Summary
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 received FDA 510(k) clearance under submission number K984478, 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 1998-12-22.
- Submission: K984478
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1998-12-22
Classification & Regulation
This clearance is catalogued under FDA product code LKJ and 21 CFR 866.5100, within the Immunology review panel as a Class II device.