Clearance Summary
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System received FDA 510(k) clearance under submission number K182063, 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: K182063
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 2018-10-30
Classification & Regulation
This clearance is catalogued under FDA product code JFY and 21 CFR 862.1225, within the Clinical Chemistry review panel as a Class II device.