Clearance Summary
TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System received FDA 510(k) clearance under submission number K173345, sponsored by Taidoc Technology Corporation. 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 2018-05-04.
- Submission: K173345
- Applicant / Sponsor: Taidoc Technology Corporation
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1435
- Decision date: 2018-05-04
Classification & Regulation
This clearance is catalogued under FDA product code JIN and 21 CFR 862.1435, within the Clinical Chemistry review panel as a Class I device.