Clearance Summary
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY received FDA 510(k) clearance under submission number K951321, 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 1995-08-24.
- Submission: K951321
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1700
- Decision date: 1995-08-24
Classification & Regulation
This clearance is catalogued under FDA product code KLI and 21 CFR 862.1700, within the Clinical Chemistry review panel as a Class II device.