Clearance Summary
ACCU-CHEK Guide Blood Glucose Monitoring System received FDA 510(k) clearance under submission number K160944, sponsored by Roche Diabetes Care, 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 2016-08-31.
- Submission: K160944
- Applicant / Sponsor: Roche Diabetes Care, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2016-08-31
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.