Clearance Summary
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III received FDA 510(k) clearance under submission number K052819, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2005-12-23.
- Submission: K052819
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5130
- Decision date: 2005-12-23
Classification & Regulation
This clearance is catalogued under FDA product code DEM and 21 CFR 866.5130, within the Immunology review panel as a Class II device.