Clearance Summary
BIONIME DIABETES MANAGEMENT SYSTEM VI.0 received FDA 510(k) clearance under submission number K113007, 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 2012-02-27.
- Submission: K113007
- Applicant / Sponsor: Bionime Corporation
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2100
- Decision date: 2012-02-27
Classification & Regulation
This clearance is catalogued under FDA product code JQP and 21 CFR 862.2100, within the Clinical Chemistry review panel as a Class I device.