Clearance Summary
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System received FDA 510(k) clearance under submission number K160365, sponsored by Infopia Co, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2016-09-28.
- Submission: K160365
- Applicant / Sponsor: Infopia Co, Ltd.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2016-09-28
Classification & Regulation
This clearance is catalogued under FDA product code NBW and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.