Clearance Summary
iChemVELOCITY Automated Urine Chemistry System received FDA 510(k) clearance under submission number K171083, sponsored by Iris Diagnostics, A Division of Iris International, 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 2017-05-12.
- Submission: K171083
- Applicant / Sponsor: Iris Diagnostics, A Division of Iris International, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1340
- Decision date: 2017-05-12
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.