Clearance Summary
Assure Titanium Blood Glucose Monitoring System received FDA 510(k) clearance under submission number K200788, sponsored by Arkray, Inc.. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2022-05-23.
- Submission: K200788
- Applicant / Sponsor: Arkray, Inc.
- Clearance pathway: Dual Track
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2022-05-23
Classification & Regulation
This clearance is catalogued under FDA product code PZI and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.