FDA Product Code GIZ: Plasma, Control, Normal
Leading manufacturers include Dade Behring, Inc., Sigma Diagnostics, Inc. and Analytical Control Systems, Inc..
20
Total
20
Cleared
117d
Avg days
1988
Since
FDA 510(k) Cleared Plasma, Control, Normal Devices (Product Code GIZ)
20 devices
Cleared
Dec 02, 2004
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
Dade Behring, Inc.
Hematology
38d
Cleared
Nov 01, 2002
CONTROL PLASMA N
Dade Behring, Inc.
Hematology
29d
Cleared
Mar 01, 2001
ACCUCLOT CONTROL I, MODEL A4089
Sigma Diagnostics, Inc.
Hematology
128d
Cleared
May 24, 2000
CONTROL PLASMA N
Dade Behring, Inc.
Hematology
35d
Cleared
Dec 01, 1998
COAGULATION CONTROL LEVEL 1 (NORMAL)
Pacific Hemostasis
Hematology
13d
Cleared
Oct 31, 1997
ACCUCOLOR HIGH CALIBRATOR (A3089)
Sigma Diagnostics, Inc.
Hematology
59d
Cleared
Aug 13, 1996
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
Cardiovascular Diagnostics, Inc.
Hematology
95d
Cleared
Oct 07, 1994
SPECIALTY ASSAYED CONTROL-1
Helena Laboratories
Hematology
183d
Cleared
Feb 22, 1994
CONTROL PLASMA N
Behring Diagnostics, Inc.
Hematology
540d
Cleared
Oct 18, 1993
COAGULATION REFERENCE PLASMA, NORMAL
American Diagnostic Corp.
Hematology
167d
Cleared
Jun 09, 1992
UNICALIBRATOR KIT
American Bioproducts Co.
Hematology
40d
Cleared
Dec 28, 1990
COAGULATION REFERENCE PLASMA, NORMAL
Medical Diagnostic Technologies, Inc.
Hematology
38d
Cleared
Oct 06, 1989
NORMAL COAGULATION CONTROL PLASMA (NCCP)
Medical Diagnostic Technologies, Inc.
Hematology
45d
Cleared
Jun 23, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I
Analytical Control Systems, Inc.
Hematology
32d
Cleared
Jun 23, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
Analytical Control Systems, Inc.
Hematology
32d
Cleared
May 06, 1988
CLP NORMAL COAGULATION CONTROL
Creative Laboratory Products, Inc.
Hematology
74d