FDA 510(k) Applications for Medical Device Product Code: DEW (Igg, Antigen, Antiserum, Control)

FDA 510(k) Applications for Medical Device Product Code "DEW"
(Igg, Antigen, Antiserum, Control)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K983221	ABBOTT LABORATORIES	IGG	11/04/1998
K963974	BECKMAN INSTRUMENTS, INC.	IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN	03/06/1997
K963868	BECKMAN INSTRUMENTS, INC.	IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)	02/10/1997
K965108	BECKMAN INSTRUMENTS, INC.	SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT	03/06/1997
K010617	HELENA LABORATORIES	SPIFE IFE CALIBRATOR AND CONTROL KIT	03/15/2001
K962202	INSTRUMENTATION LABORATORY CO.	QUANTEX IGG	09/26/1996
K993281	KAMIYA BIOMEDICAL CO.	K-ASSAY IGG	11/09/1999
K955798	RANDOX LABORATORIES, LTD.	IGG IMMUNOTURBIDIMETRIC & CALIBRATOR	04/05/1996
K040434	ROCHE DIAGNOSTICS CORP.	ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2	03/10/2004
K050113	ROCHE DIAGNOSTICS CORP.	TINA-QUANT IGG GEN.2	02/08/2005
K993928	WAKO CHEMICALS, USA, INC.	WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD	01/18/2000