Clearance Summary
TRUE METRIX GO Self Monitoring Blood Glucose System received FDA 510(k) clearance under submission number K143548, sponsored by Trividia Health, 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 2016-04-01.
- Submission: K143548
- Applicant / Sponsor: Trividia Health, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2016-04-01
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.