Clearance Summary
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES received FDA 510(k) clearance under submission number K120765, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2012-10-24.
- Submission: K120765
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1160
- Decision date: 2012-10-24
Classification & Regulation
This clearance is catalogued under FDA product code KHS and 21 CFR 862.1160, within the Clinical Chemistry review panel as a Class II device.