Clearance Summary
VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 received FDA 510(k) clearance under submission number K082099, 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 2008-08-21.
- Submission: K082099
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1170
- Decision date: 2008-08-21
Classification & Regulation
This clearance is catalogued under FDA product code CGZ and 21 CFR 862.1170, within the Clinical Chemistry review panel as a Class II device.