Clearance Summary
RADIAS PHENYLALANINE TEST received FDA 510(k) clearance under submission number K960437, 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 1996-08-16.
- Submission: K960437
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1555
- Decision date: 1996-08-16
Classification & Regulation
This clearance is catalogued under FDA product code JNB and 21 CFR 862.1555, within the Clinical Chemistry review panel as a Class II device.