Clearance Summary
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM received FDA 510(k) clearance under submission number K022329, sponsored by Bayer Diagnostics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2002-11-27.
- Submission: K022329
- Applicant / Sponsor: Bayer Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2002-11-27
Classification & Regulation
This clearance is catalogued under FDA product code LTK and 21 CFR 866.6010, within the Immunology review panel as a Class II device.