Clearance Summary
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides received FDA 510(k) clearance under submission number K182072, sponsored by Ortho-Clinical Diagnostics, 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 2018-10-30.
- Submission: K182072
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1170
- Decision date: 2018-10-30
Classification & Regulation
This clearance is catalogued under FDA product code CGZ and 21 CFR 862.1170, within the Clinical Chemistry review panel as a Class II device.