Clearance Summary
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION received FDA 510(k) clearance under submission number K121654, sponsored by I-Sens, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2012-09-05.
- Submission: K121654
- Applicant / Sponsor: I-Sens, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2012-09-05
Classification & Regulation
This clearance is catalogued under FDA product code CGA and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.