Clearance Summary
VITROS Chemistry Products Calibrator Kit 3 received FDA 510(k) clearance under submission number K161140, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2016-05-20.
- Submission: K161140
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2016-05-20
Classification & Regulation
This clearance is catalogued under FDA product code JIX and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.