Clearance Summary
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. received FDA 510(k) clearance under submission number K153551, sponsored by Axis-Shield Diagnostics Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2016-08-04.
- Submission: K153551
- Applicant / Sponsor: Axis-Shield Diagnostics Limited
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 2016-08-04
Classification & Regulation
This clearance is catalogued under FDA product code NHX and 21 CFR 866.5775, within the Immunology review panel as a Class II device.