Clearance Summary
VITROS XT Chemistry Products TBIL-ALKP Slides received FDA 510(k) clearance under submission number K190807, 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 2019-04-26.
- Submission: K190807
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1110
- Decision date: 2019-04-26
Classification & Regulation
This clearance is catalogued under FDA product code CIG and 21 CFR 862.1110, within the Clinical Chemistry review panel as a Class II device.