Clearance Summary
U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System received FDA 510(k) clearance under submission number K151100, sponsored by Taidoc Technology Corporation. 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 2015-09-29.
- Submission: K151100
- Applicant / Sponsor: Taidoc Technology Corporation
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2015-09-29
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.