FDA 510(k) Applications for Medical Device Product Code: GIZ (Plasma, Control, Normal)

FDA 510(k) Applications for Medical Device Product Code "GIZ"
(Plasma, Control, Normal)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K961814	CARDIOVASCULAR DIAGNOSTICS, INC.	THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS	08/13/1996
K023309	DADE BEHRING, INC.	CONTROL PLASMA N	11/01/2002
K001256	DADE BEHRING, INC.	CONTROL PLASMA N	05/24/2000
K042941	DADE BEHRING, INC.	DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS	12/02/2004
K984129	PACIFIC HEMOSTASIS	COAGULATION CONTROL LEVEL 1 (NORMAL)	12/01/1998
K013708	PRECISION BIOLOGIC	REFERENCE CHECK, CATALOG NUMBER-RCN-10	12/10/2001
K003328	SIGMA DIAGNOSTICS, INC.	ACCUCLOT CONTROL I, MODEL A4089	03/01/2001
K973274	SIGMA DIAGNOSTICS, INC.	ACCUCOLOR HIGH CALIBRATOR (A3089)	10/31/1997
K060968	WORTHAM LABORATORIES INC	STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW	05/15/2007