Clearance Summary
ACCU-CHEK ULTRFLEX INFUSION SET received FDA 510(k) clearance under submission number K101196, sponsored by Roche Diagnostics Corp.. 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 2010-08-27.
- Submission: K101196
- Applicant / Sponsor: Roche Diagnostics Corp.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2010-08-27
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.