Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY received FDA 510(k) clearance under submission number K983031, 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 1998-12-18.
- Submission: K983031
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 1998-12-18
Classification & Regulation
This clearance is catalogued under FDA product code LOJ and 21 CFR 866.6010, within the Immunology review panel as a Class II device.