Clearance Summary
GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK received FDA 510(k) clearance under submission number K081403, sponsored by Bionostics, 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 2008-07-25.
- Submission: K081403
- Applicant / Sponsor: Bionostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2008-07-25
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.