Clearance Summary
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker received FDA 510(k) clearance under submission number K160915, sponsored by Roche 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 2016-12-14.
- Submission: K160915
- Applicant / Sponsor: Roche Diagnostics
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2016-12-14
Classification & Regulation
This clearance is catalogued under FDA product code OVK and 21 CFR 866.6010, within the Immunology review panel as a Class II device.