Clearance Summary
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM received FDA 510(k) clearance under submission number K051072, sponsored by Bio-Rad Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2005-05-12.
- Submission: K051072
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7415
- Decision date: 2005-05-12
Classification & Regulation
This clearance is catalogued under FDA product code GKA and 21 CFR 864.7415, within the Hematology review panel as a Class II device.