FDA 510(k) Applications for Medical Device Product Code: OIU (Test, Epithelial Ovarian Tumor Associated Antigen (He4))

FDA 510(k) Applications for Medical Device Product Code "OIU"
(Test, Epithelial Ovarian Tumor Associated Antigen (He4))

FDA 510(k) Number	Applicant	Device Name	Decision Date
K093957	FUJIREBIO DIAGNOSTICS, INC	ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,	03/18/2010
K103676	FUJIREBIO DIAGNOSTICS, INC.	FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL	07/19/2011
K072939	FUJIREBIO DIAGNOSTICS, INC.	HE4 EIA, MODEL: 404-10 US	06/09/2008
K151378	Fujirebio Diagnostics, Inc.	Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators	11/24/2015
K112624	Roche Diagnostics	ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5	09/10/2012