Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS received FDA 510(k) clearance under submission number K041322, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2004-06-17.
- Submission: K041322
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2004-06-17
Classification & Regulation
This clearance is catalogued under FDA product code DHX and 21 CFR 866.6010, within the Immunology review panel as a Class II device.