FDA 510(k) Applications for Medical Device Product Code: MMW (System, Test, Tumor Marker, Monitoring, Bladder)

FDA 510(k) Applications for Medical Device Product Code "MMW"
(System, Test, Tumor Marker, Monitoring, Bladder)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K964151	BARD DIAGNOSTIC SCIENCES,INC.	BARD AND BTA TEST	04/16/1997
K971402	BARD DIAGNOSTIC SCIENCES,INC.	BARD BTA TRAK TEST	04/15/1998
K974845	BARD DIAGNOSTIC SCIENCES,INC.	BTA STAT TEST PRESCRIPTION HOME USE	12/08/1998
K021231	MATRITECH, INC.	NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT	07/30/2002
K203245	Nucleix Ltd.	Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C	05/04/2023
K970353	PERIMMUNE, INC.	AURA TEK FDP	04/30/1997
K033982	VYSIS	MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST	01/22/2004
K013785	VYSIS	UROVYSION BLADDER CANCER RECURRENCE KIT	02/08/2002
K011031	VYSIS	VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT	08/03/2001