Clearance Summary
A1C EZ Glycohemoglobin Analysis System received FDA 510(k) clearance under submission number K161533, sponsored by Biohermes Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2017-06-16.
- Submission: K161533
- Applicant / Sponsor: Biohermes Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2017-06-16
Classification & Regulation
This clearance is catalogued under FDA product code LCP and 21 CFR 864.7470, within the Hematology review panel as a Class II device.