FDA 510(k) Applications for Medical Device Product Code: NYI (Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer)

FDA 510(k) Applications for Medical Device Product Code "NYI"
(Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K101454	AGENDIA	MAMMAPRINT	01/28/2011
K141142	AGENDIA	MAMMAPRINT FFPE	01/23/2015
K081092	AGENDIA	MODIFICATION TO MAMMAPRINT	12/11/2009
DEN070009	AGENDIA BV	MAMMAPRINT	02/06/2007
K070675	AGENDIA BV	MAMMAPRINT	06/22/2007
K080252	AGENDIA BV	MODIFICATION TO MAMMAPRINT	07/21/2008
K201902	Agendia Inc.	MammaPrint	11/05/2020
K210973	Agendia Inc.	MammaPrint FFPE NGS Kit	09/08/2022
K130010	NANOSTRING TECHNOLOGIES	PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY	09/06/2013
K141771	NANOSTRING TECHNOLOGIES INC.	PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY	11/07/2014