Clearance Summary
VITROS CHEMISTRY PRODUCTS TRIG SLIDES received FDA 510(k) clearance under submission number K130332, 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 2013-05-31.
- Submission: K130332
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1705
- Decision date: 2013-05-31
Classification & Regulation
This clearance is catalogued under FDA product code CDT and 21 CFR 862.1705, within the Clinical Chemistry review panel as a Class I device.