Clearance Summary
VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH received FDA 510(k) clearance under submission number K080911, sponsored by Bio-Rad Laboratories Inc., Clinical Systems Divisi. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2008-05-02.
- Submission: K080911
- Applicant / Sponsor: Bio-Rad Laboratories Inc., Clinical Systems Divisi
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7415
- Decision date: 2008-05-02
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.