FDA 510(k) Applications for Medical Device Product Code: LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer)

FDA 510(k) Applications for Medical Device Product Code "LOJ"
(Kit, Test,Alpha-Fetoprotein For Testicular Cancer)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K020806	BAYER CORP.	ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY	03/27/2002
K972462	BAYER CORP.	AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM	09/22/1997
K020807	BAYER DIAGNOSTICS CORP.	AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	10/01/2002
K981354	BECKMAN INSTRUMENTS, INC.	ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211	05/01/1998
K080017	BIOMERIEUX, INC.	VIDAS AFP ASSAY	09/26/2008
K973351	BOEHRINGER MANNHEIM CORP.	ELECSYS AFP	11/21/1997
K071597	DADE BEHRING, INC.	DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600	06/04/2008
K983263	DIAGNOSTIC PRODUCTS CORP.	IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2	12/07/1998
K990138	DIAGNOSTIC SYSTEMS LABORATORIES, INC.	DSL ACTIVE AFP ELISA, MODEL DSL-10-8400	06/21/1999
K081709	OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)	OLYMPUS AFP - ALPHA-FETOPROTEIN	03/16/2009
K213626	Ortho Clinical Diagnostics	VITROS AFP	06/15/2022
K983031	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY	12/18/1998
K220176	Roche Diagnostics	Elecsys AFP	09/15/2022
K981282	ROCHE DIAGNOSTICS GMBH	ELECSYS AFP	05/01/1998
K090236	SIEMENS HEALTHCARE DIAGNOSTICS	DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454	04/27/2009
K023894	TOSOH MEDICS, INC.	ST AIA-PACK AFP ENZYME IMMUNOASSAY	12/17/2002