FDA 510(k) Applications for Medical Device Product Code: LBZ (Enzyme Immunoassay, Quinidine)

FDA 510(k) Applications for Medical Device Product Code "LBZ"
(Enzyme Immunoassay, Quinidine)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K964116	BAYER CORP.	QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)	12/24/1996
K964212	DIAGNOSTIC REAGENTS, INC.	QUINIDINE ENZYME IMMUNOASSAY	12/18/1996
K955568	OXIS INTL., INC.	INNOFLUOR QUINIDINE ASSAY SYSTEM	04/04/1996
K032332	ROCHE DIAGNOSTICS CORP.	ROCHE ONLINE TDM QUINIDINE	01/12/2004
K052826	SERADYN INC.	QMS QUINIDINE. QMS QUINIDINE CALIBRATORS	12/23/2005
K011605	SYVA CO., DADE BEHRING, INC.	EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229	06/12/2001