Clearance Summary
D-100 HbA1c, D-100 HbA1c Calibrator Pack received FDA 510(k) clearance under submission number K151321, sponsored by Bio-Rad Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2015-12-09.
- Submission: K151321
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1373
- Decision date: 2015-12-09
Classification & Regulation
This clearance is catalogued under FDA product code PDJ and 21 CFR 862.1373, within the Clinical Chemistry review panel as a Class II device.