Clearance Summary
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; received FDA 510(k) clearance under submission number K093611, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2010-04-15.
- Submission: K093611
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1160
- Decision date: 2010-04-15
Classification & Regulation
This clearance is catalogued under FDA product code KHS and 21 CFR 862.1160, within the Clinical Chemistry review panel as a Class II device.