Clearance Summary
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 received FDA 510(k) clearance under submission number K120423, sponsored by Bionime 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 2012-08-03.
- Submission: K120423
- Applicant / Sponsor: Bionime Corporation
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2012-08-03
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.