FDA 510(k) Applications for Medical Device Product Code: NIG (System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer)

FDA 510(k) Applications for Medical Device Product Code "NIG"
(System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K031393	BAYER HEALTHCARE, LLC	BAYER ADVIA CENTAUR CA 19-9 ASSAY	06/24/2003
K033038	BECKMAN COULTER, INC.	GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688	12/29/2003
K052000	FUJIREBIO DIAGNOSTICS, INC.	ARCHITECT CA 19-9XR ASSAY	10/25/2005
K020566	FUJIREBIO DIAGNOSTICS, INC.	FUJIREBIO DIAGNOSTICS CA 19-9 RIA	05/09/2002
K200997	Fujirebio Diagnostics, Inc.	Lumipulse G CA19-9-N	05/14/2020
K052889	FUJIREBIO DIAGNOSTICS, INC.	VITROS CA 19-9	12/20/2005
K191973	Fujirebio Dianostics, Inc.	Lumpipulse G CA19-9-N	10/22/2019
K231525	Ortho Clinical Diagnostics	VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack	08/09/2023
K100375	Siemens Healthcare Diagnostics Inc.	DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604	04/06/2011
K023239	TOSOH CORP.	AIA-PACK CA 19-9	12/23/2002
K023240	TOSOH CORP.	ST AIA-PACK CA 19-9	12/23/2002