FDA 510(k) Applications for Medical Device Product Code: LAR (Enzyme Immunoassay, Procainamide)

FDA 510(k) Applications for Medical Device Product Code "LAR"
(Enzyme Immunoassay, Procainamide)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K955444	ABBOTT LABORATORIES	ABBOTT AXSM PROCAINAMIDE ASSAY	04/02/1996
K971716	BAYER CORP.	PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM	06/27/1997
K963306	BOEHRINGER MANNHEIM CORP.	CEDIA N-ACETYLPROCAINAMIDE ASSAY	10/29/1996
K962099	BOEHRINGER MANNHEIM CORP.	CEDIA PROCAINAMIDE ASSAY	08/27/1996
K032573	DADE BEHRING, INC.	DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110	10/31/2003
K962463	DIAGNOSTIC REAGENTS, INC.	PROCAINAMIDE ENZYME IMMUNOASSAY	08/14/1996
K060773	ROCHE DIAGNOSTICS CORP.	ONLINE TDM PROCAINAMIDE	08/23/2006
K010812	SYVA CO., DADE BEHRING, INC.	EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229	04/13/2001