Clearance Summary
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY received FDA 510(k) clearance under submission number K072443, 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 2007-09-24.
- Submission: K072443
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1145
- Decision date: 2007-09-24
Classification & Regulation
This clearance is catalogued under FDA product code CJY and 21 CFR 862.1145, within the Clinical Chemistry review panel as a Class II device.