Clearance Summary
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE received FDA 510(k) clearance under submission number K043529, sponsored by Roche Diagnostics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2005-04-08.
- Submission: K043529
- Applicant / Sponsor: Roche Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1890
- Decision date: 2005-04-08
Classification & Regulation
This clearance is catalogued under FDA product code NDC and 21 CFR 868.1890, within the Anesthesiology review panel as a Class II device.