Clearance Summary
VITROS XT Chemistry Products UREA-CREA Slides received FDA 510(k) clearance under submission number K190326, 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 2019-03-14.
- Submission: K190326
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1770
- Decision date: 2019-03-14
Classification & Regulation
This clearance is catalogued under FDA product code CDN and 21 CFR 862.1770, within the Clinical Chemistry review panel as a Class II device.