Clearance Summary
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 received FDA 510(k) clearance under submission number K083680, 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 2009-02-27.
- Submission: K083680
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1600
- Decision date: 2009-02-27
Classification & Regulation
This clearance is catalogued under FDA product code CEM and 21 CFR 862.1600, within the Clinical Chemistry review panel as a Class II device.