FDA 510(k) Applications for Medical Device Product Code: MKW (Cyclosporine)

FDA 510(k) Applications for Medical Device Product Code "MKW"
(Cyclosporine)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K040761	ABBOTT LABORATORIES INC	AXSYM CYCLOSPORINE	04/30/2004
K023065	DADE BEHRING, INC.	CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE	10/16/2002
K052017	DADE BEHRING, INC.	CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108	09/01/2005
K062236	DADE BEHRING, INC.	DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE	08/21/2006
K053061	DADE BEHRING, INC.	EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY	02/06/2006
K080751	FUJIREBIO DIAGNOSTICS, INC.	ARCHITECT CYCLOSPORINE	09/11/2008
K023208	MICROGENICS CORP.	CEDIA CYCLOSPORINE PLUS ASSAY	10/24/2002
K081992	Siemens Healthcare Diagnostics Inc.	DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108	08/05/2008
K071455	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS	ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR	09/11/2008