Panels › Hematology › Product code GIZ · Class 2

Plasma, Control, Normal

Regulation 864.5425

0510(k)s in 12 months (20 all time)

0recalls in 12 months (1 all time)

1recalls that name a 510(k)

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Top companies in GIZ

Company	510(k)s	Recalls
Dade Behring, Inc.	3	0
Analytical Control Systems, Inc.	2	0
Medical Diagnostic Technologies, Inc.	2	0
Sigma Diagnostics, Inc.	2	0
American Bioproducts Co.	1	0
American Diagnostic Corp.	1	0
American Diagnostica, Inc.	1	0
Behring Diagnostics, Inc.	1	0
Cardiovascular Diagnostics, Inc.	1	0
Creative Laboratory Products, Inc.	1	0

Decided	510(k)	Device and applicant	Code
May 15, 2007	K060968	STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW Wortham Laboratories, Inc.	GIZ
Dec 2, 2004	K042941	DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS Dade Behring, Inc.	GIZ
Nov 1, 2002	K023309	CONTROL PLASMA N Dade Behring, Inc.	GIZ
Dec 10, 2001	K013708	REFERENCE CHECK, CATALOG NUMBER-RCN-10 Precision Biologic, CA	GIZ
Mar 1, 2001	K003328	ACCUCLOT CONTROL I, MODEL A4089 Sigma Diagnostics, Inc.	GIZ
May 24, 2000	K001256	CONTROL PLASMA N Dade Behring, Inc.	GIZ
Dec 1, 1998	K984129	COAGULATION CONTROL LEVEL 1 (NORMAL) Pacific Hemostasis	GIZ
Oct 31, 1997	K973274	ACCUCOLOR HIGH CALIBRATOR (A3089) Sigma Diagnostics, Inc.	GIZ
Aug 13, 1996	K961814	THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS Cardiovascular Diagnostics, Inc.	GIZ
Oct 7, 1994	K941737	SPECIALTY ASSAYED CONTROL-1 Helena Laboratories	GIZ
Sep 19, 1994	K935254	DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA American Diagnostica, Inc.	GIZ
Feb 22, 1994	K924403	CONTROL PLASMA N Behring Diagnostics, Inc.	GIZ
Oct 18, 1993	K932145	COAGULATION REFERENCE PLASMA, NORMAL American Diagnostic Corp.	GIZ
Jun 9, 1992	K922021	UNICALIBRATOR KIT American Bioproducts Co.	GIZ
Dec 28, 1990	K905203	COAGULATION REFERENCE PLASMA, NORMAL Medical Diagnostic Technologies, Inc.	GIZ
Oct 6, 1989	K895262	NORMAL COAGULATION CONTROL PLASMA (NCCP) Medical Diagnostic Technologies, Inc.	GIZ
Jun 23, 1989	K893784	ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I Analytical Control Systems, Inc.	GIZ
Jun 23, 1989	K893783	ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I Analytical Control Systems, Inc.	GIZ
Apr 10, 1989	K891179	EDL NORMAL COAGULATION CONTROL Elite Diagnostic , Ltd.	GIZ
May 6, 1988	K880712	CLP NORMAL COAGULATION CONTROL Creative Laboratory Products, Inc.	GIZ

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