FDA 510(k) Applications for Medical Device Product Code: GHH (Fibrin Split Products)

FDA 510(k) Applications for Medical Device Product Code "GHH"
(Fibrin Split Products)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K993276	AGEN BIOMEDICAL LTD.	SIMPLIFY D-DIMER, MODEL DCGK1	12/14/1999
K972316	BEHRING DIAGNOSTICS, INC.	OPUS D-DIMER	09/09/1997
K021877	BIOMERIEUX, INC.	MDA D-DIMER	08/07/2002
K042890	BIOSITE INCORPORATED	TRIAGE D-DIMER TEST, MODEL 98100	11/29/2004
K112120	DIAZYME LABORATORIES	DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET	01/24/2013
K072288	MITSUBISHI KAGAKU IATRON	PATHFAST D-DIMER	05/06/2009
K070453	OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH	OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL	06/11/2007
K030740	ROCHE DIAGNOSTICS CORP.	MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM	04/01/2003
K062203	ROCHE DIAGNOSTICS CORP.	TINA-QUANT D-DIMER TEST SYSTEM	03/14/2007
K011143	ROCHE DIAGNOSTICS CORP.	TINA-QUANT D-DIMER TEST SYSTEM	05/29/2001