Clearance Summary
BIO-RAD CODA NEONATAL GALT ASSAY received FDA 510(k) clearance under submission number K993536, sponsored by Bio-Rad. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1999-11-04.
- Submission: K993536
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1315
- Decision date: 1999-11-04
Classification & Regulation
This clearance is catalogued under FDA product code KQP and 21 CFR 862.1315, within the Clinical Chemistry review panel as a Class II device.