Clearance Summary
QUANTIGEN T & B CELL ASSAY received FDA 510(k) clearance under submission number K831053, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1983-08-08.
- Submission: K831053
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 1983-08-08
Classification & Regulation
This clearance is catalogued under FDA product code LIZ and 21 CFR 864.5220, within the Hematology review panel as a Class II device.