Clearance Summary
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 received FDA 510(k) clearance under submission number K071215, 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 2007-05-25.
- Submission: K071215
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 2007-05-25
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.