Clearance Summary
RADIAS RED CELL FOLATE IMMUNOASAY received FDA 510(k) clearance under submission number K944212, 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 1995-02-03.
- Submission: K944212
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1295
- Decision date: 1995-02-03
Classification & Regulation
This clearance is catalogued under FDA product code CGN and 21 CFR 862.1295, within the Clinical Chemistry review panel as a Class II device.