Clearance Summary
D-10 Hemoglobin A1c Program received FDA 510(k) clearance under submission number K161687, 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 2016-10-14.
- Submission: K161687
- 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: 2016-10-14
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.