FDA 510(k) Applications for Medical Device Product Code: MSJ (Apolipoproteins)

FDA 510(k) Applications for Medical Device Product Code "MSJ"
(Apolipoproteins)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K992662	BAYER CORP.	8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM	02/15/2000
K964010	BECKMAN INSTRUMENTS, INC.	IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT	02/10/1997
K970314	BECKMAN INSTRUMENTS, INC.	SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS	04/21/1997
K063608	DADE BEHRING, INC.	DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH	02/23/2007
K073488	DIAZYME LABORATORIES	DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX	03/07/2008
K072977	GENERAL ATOMICS	DIAZYME APOLIPOPROTEIN A-1 ASSAY	07/16/2008
K061377	POINTE SCIENTIFIC, INC.	APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS	03/28/2007