Clearance Summary
RADIAS B12 ENZYME IMMUNOASSAY received FDA 510(k) clearance under submission number K933315, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1993-08-25.
- Submission: K933315
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1810
- Decision date: 1993-08-25
Classification & Regulation
This clearance is catalogued under FDA product code CDD and 21 CFR 862.1810, within the Clinical Chemistry review panel as a Class II device.