Clearance Summary
3TEST SUPREME GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance under submission number K072905, sponsored by Neuero Engineering, 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 2008-04-18.
- Submission: K072905
- Applicant / Sponsor: Neuero Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2008-04-18
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.