GIZ · Class II · 21 CFR 864.5425

FDA Product Code GIZ: Plasma, Control, Normal

Leading manufacturers include Dade Behring, Inc., Analytical Control Systems, Inc. and Medical Diagnostic Technologies, Inc..

20
Total
20
Cleared
117d
Avg days
1988
Since

FDA 510(k) Cleared Plasma, Control, Normal Devices (Product Code GIZ)

20 devices
1–20 of 20
Cleared May 15, 2007
STASIS - I, II AND III
K060968
Wortham Laboratories, Inc.
Hematology · 403d
Cleared Dec 02, 2004
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
K042941
Dade Behring, Inc.
Hematology · 38d
Cleared Nov 01, 2002
CONTROL PLASMA N
K023309
Dade Behring, Inc.
Hematology · 29d
Cleared Dec 10, 2001
REFERENCE CHECK, CATALOG NUMBER-RCN-10
K013708
Precision Biologic
Hematology · 32d
Cleared Mar 01, 2001
ACCUCLOT CONTROL I, MODEL A4089
K003328
Sigma Diagnostics, Inc.
Hematology · 128d
Cleared May 24, 2000
CONTROL PLASMA N
K001256
Dade Behring, Inc.
Hematology · 35d
Cleared Dec 01, 1998
COAGULATION CONTROL LEVEL 1 (NORMAL)
K984129
Pacific Hemostasis
Hematology · 13d
Cleared Oct 31, 1997
ACCUCOLOR HIGH CALIBRATOR (A3089)
K973274
Sigma Diagnostics, Inc.
Hematology · 59d
Cleared Aug 13, 1996
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
K961814
Cardiovascular Diagnostics, Inc.
Hematology · 95d
Cleared Oct 07, 1994
SPECIALTY ASSAYED CONTROL-1
K941737
Helena Laboratories
Hematology · 183d
Cleared Sep 19, 1994
DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA
K935254
American Diagnostica, Inc.
Hematology · 322d
Cleared Feb 22, 1994
CONTROL PLASMA N
K924403
Behring Diagnostics, Inc.
Hematology · 540d
Cleared Oct 18, 1993
COAGULATION REFERENCE PLASMA, NORMAL
K932145
American Diagnostic Corp.
Hematology · 167d
Cleared Jun 09, 1992
UNICALIBRATOR KIT
K922021
American Bioproducts Co.
Hematology · 40d
Cleared Dec 28, 1990
COAGULATION REFERENCE PLASMA, NORMAL
K905203
Medical Diagnostic Technologies, Inc.
Hematology · 38d
Cleared Oct 06, 1989
NORMAL COAGULATION CONTROL PLASMA (NCCP)
K895262
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared Jun 23, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I
K893783
Analytical Control Systems, Inc.
Hematology · 32d
Cleared Jun 23, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
K893784
Analytical Control Systems, Inc.
Hematology · 32d
Cleared Apr 10, 1989
EDL NORMAL COAGULATION CONTROL
K891179
Elite Diagnostic , Ltd.
Hematology · 35d
Cleared May 06, 1988
CLP NORMAL COAGULATION CONTROL
K880712
Creative Laboratory Products, Inc.
Hematology · 74d

About Product Code GIZ - Regulatory Context