FDA 510(k) Applications for Medical Device Product Code: GGC (Control, Plasma, Abnormal)

FDA 510(k) Applications for Medical Device Product Code "GGC"
(Control, Plasma, Abnormal)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K955040	AMERICAN BIOPRODUCTS CO.	AT-III CONTROL PLASMA KIT	01/31/1996
K020878	BIO-RAD	LYPHOCHEK HEMOSTASIS, MODELS 798, 799	04/15/2002
K023312	DADE BEHRING, INC.	CONTROL PLASMA P	11/01/2002
K061803	DIAGNOSTICA STAGO, INC.	STA - CONTROL LA 1+2	07/28/2006
K993332	GRADIPORE LTD.	GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05	02/16/2000
K100103	HELENA LABORATORIES	SPECIALTY ASSAYED CONTROL-2	12/15/2010
K102552	INSTRUMENTATION LABORATORY CO.	HEMOSIL LA POSITIVE CONTROL	04/05/2011
K012422	KAMIYA BIOMEDICAL CO.	K-ASSAY D-DIMER CONTROLS	08/21/2001
K961370	MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.	LA POSITIVE CONTROL PLASMA	05/24/1996
K984130	PACIFIC HEMOSTASIS	COAGULATION CONTROL LEVEL 2 (ABNORMAL)	12/01/1998
K984131	PACIFIC HEMOSTASIS	COAGULATION CONTROL LEVEL 3 (ABNORMAL)	12/01/1998
K032804	PRECISION BIOLOGIC	CRYOCHECK WEAK LUPUS POSITIVE CONTROL	11/03/2003
K062306	R2 DIAGNOSTICS, INC.	PLASMACON N, PLASMACON L-1, PLASMACON L-2	03/16/2007
K020109	SIGMA DIAGNOSTICS, INC.	SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL	02/06/2002
K003329	SIGMA DIAGNOSTICS, INC.	SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217	03/01/2001