Clearance Summary
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System received FDA 510(k) clearance under submission number K170463, sponsored by I-Sens, 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 2018-04-13.
- Submission: K170463
- Applicant / Sponsor: I-Sens, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1435
- Decision date: 2018-04-13
Classification & Regulation
This clearance is catalogued under FDA product code JIN and 21 CFR 862.1435, within the Clinical Chemistry review panel as a Class I device.