Name: Predicase
Price: 199 USD

K-number	K153551
Device name	ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
Applicant	Axis-Shield Diagnostics Limited
Product code	NHX
Device class	Class II
Decision date	Aug 4, 2016
Decision	Substantially Equivalent
Regulation	866.5775

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

Everything you need for a 510(k) submission. Nothing you don't.