Clearance Summary
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM received FDA 510(k) clearance under submission number K063144, 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 2006-11-13.
- Submission: K063144
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2160
- Decision date: 2006-11-13
Classification & Regulation
This clearance is catalogued under FDA product code JJE and 21 CFR 862.2160, within the Clinical Chemistry review panel as a Class I device.