Clearance Summary
ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) received FDA 510(k) clearance under submission number K093819, sponsored by Arkray Factory USA, 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 2010-06-09.
- Submission: K093819
- Applicant / Sponsor: Arkray Factory USA, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2010-06-09
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.