Clearance Summary
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software received FDA 510(k) clearance under submission number K171664, sponsored by Bio-Rad Laboratories, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2017-09-13.
- Submission: K171664
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7415
- Decision date: 2017-09-13
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.