Clearance Summary
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY received FDA 510(k) clearance under submission number K935399, 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 1994-12-19.
- Submission: K935399
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1690
- Decision date: 1994-12-19
Classification & Regulation
This clearance is catalogued under FDA product code JLW and 21 CFR 862.1690, within the Clinical Chemistry review panel as a Class II device.