Clearance Summary
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE received FDA 510(k) clearance under submission number K082595, sponsored by Roche Diagnostics. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2008-10-28.
- Submission: K082595
- Applicant / Sponsor: Roche Diagnostics
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2008-10-28
Classification & Regulation
This clearance is catalogued under FDA product code LZG and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.