Clearance Summary
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) received FDA 510(k) clearance under submission number K983715, sponsored by Bayer 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 1999-05-14.
- Submission: K983715
- Applicant / Sponsor: Bayer Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 1999-05-14
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.