Clearance Summary
Elecsys CA-125 II assay received FDA 510(k) clearance under submission number K143534, sponsored by Roche Professional Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2015-08-06.
- Submission: K143534
- Applicant / Sponsor: Roche Professional Diagnostics
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2015-08-06
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.