FDA 510(k) Applications for Medical Device Product Code: ONX (Ovarian Adnexal Mass Assessment Score Test System)

FDA 510(k) Applications for Medical Device Product Code "ONX"
(Ovarian Adnexal Mass Assessment Score Test System)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K151502	Fujirebio Diagnostics, Inc.	ARCHITECT ROMA	04/28/2016
K160090	Fujirebio Diagnostics, Inc.	Lumipulse G ROMA	05/16/2016
K103358	FUJIREBIO DIAGNOSTICS, INC.	ROMA (HE4 EIA + ARCHITECT CA 125 II)	09/01/2011
K153607	ROCHE DIAGNOSTICS	ROMA Calculation Tool Using Elecsys Assays	06/15/2016
DEN090004	VERMILLION	OVA1 TEST	09/11/2009
K150588	VERMILLION, INC.	OVA1 Next Generation	03/18/2016