Clearance Summary
inui In-Home Urine Analysis Test System received FDA 510(k) clearance under submission number K180356, sponsored by Scanadu, 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 2018-05-25.
- Submission: K180356
- Applicant / Sponsor: Scanadu, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1340
- Decision date: 2018-05-25
Classification & Regulation
This clearance is catalogued under FDA product code JIL and 21 CFR 862.1340, within the Clinical Chemistry review panel as a Class II device.