Clearance Summary
VARIANT II B-THALASSEMIA received FDA 510(k) clearance under submission number K991127, sponsored by Bio-Rad. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1999-06-10.
- Submission: K991127
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7400
- Decision date: 1999-06-10
Classification & Regulation
This clearance is catalogued under FDA product code JPD and 21 CFR 864.7400, within the Hematology review panel as a Class II device.