510(k) K153551

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. by Axis-Shield Diagnostics Limited — Product Code NHX

K153551 is an FDA 510(k) premarket notification submitted by Axis-Shield Diagnostics Limited for the device "ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.". The FDA issued a decision of Substantially Equivalent on August 4, 2016. The device falls under product code NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)), a Class II device regulated under 21 CFR 866.5775. Axis-Shield Diagnostics Limited has at least 3 other 510(k) clearances on record.