Clearance Summary
RADIAS ANA SCREEN ENZYME IMMUNOASSAY received FDA 510(k) clearance under submission number K941509, 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 1994-06-30.
- Submission: K941509
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1994-06-30
Classification & Regulation
This clearance is catalogued under FDA product code LJM and 21 CFR 866.5100, within the Immunology review panel as a Class II device.