Clearance Summary
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT received FDA 510(k) clearance under submission number K101852, sponsored by Iris International Inc., A Division of Iris Iris I. 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 2011-03-23.
- Submission: K101852
- Applicant / Sponsor: Iris International Inc., A Division of Iris Iris I
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2900
- Decision date: 2011-03-23
Classification & Regulation
This clearance is catalogued under FDA product code KQO and 21 CFR 862.2900, within the Clinical Chemistry review panel as a Class I device.