Clearance Summary
KetoSens BT Blood B-Ketone Monitoring System received FDA 510(k) clearance under submission number K201551, 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 2020-09-09.
- Submission: K201551
- Applicant / Sponsor: I-Sens, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1435
- Decision date: 2020-09-09
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.