FDA Product Code GGN: Plasma, Coagulation Control
Leading manufacturers include Helena Laboratories, Bio-Rad and Instrumentation Laboratory CO.
99
Total
99
Cleared
127d
Avg days
1977
Since
99 devices
Cleared
Sep 18, 2001
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
Bio-Rad
Hematology
34d
Cleared
Nov 22, 1999
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
Medical Analysis Systems, Inc.
Hematology
91d
Cleared
Apr 21, 1999
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
Bio-Rad
Hematology
37d
Cleared
Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
Sigma Diagnostics, Inc.
Hematology
23d
Cleared
Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
Sigma Diagnostics, Inc.
Hematology
23d
Cleared
Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
Sigma Diagnostics, Inc.
Hematology
23d
Cleared
Jun 26, 1997
STA LIATEST CONTROL [N]+[P] KIT
American Bioproducts Co.
Hematology
213d
Cleared
Feb 20, 1997
LYPHOCHEK COAGULATION CONTROL
Bio-Rad
Hematology
71d
Cleared
Jul 23, 1996
STA - VWF CONTROL [N]+[P] KIT
American Bioproducts Co.
Hematology
14d
Cleared
May 30, 1996
BEHRING COAGULATION TIMER
Behring Diagnostics, Inc.
Hematology
195d
Cleared
Mar 11, 1996
PORCINE FACTOR VIII
Helena Laboratories
Hematology
298d
Cleared
May 11, 1995
ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL
Ortho Diagnostic Systems, Inc.
Hematology
482d
Cleared
Mar 21, 1995
STA SYSTEM CONTROL [N] + [P] KIT
American Bioproducts Co.
Hematology
243d
Cleared
Mar 15, 1995
ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
International Technidyne Corp.
Hematology
173d
Cleared
Sep 14, 1994
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
Helena Laboratories
Hematology
152d
Cleared
Mar 22, 1994
COAGULATION A.R.P.
Helena Laboratories
Hematology
264d
Cleared
Dec 01, 1992
CLIBRATION PLASMAS
Behring Diagnostics, Inc.
Hematology
92d
Cleared
Oct 26, 1992
COAG-CONTROL [N] KIT
American Bioproducts Co.
Hematology
171d
Cleared
Jun 09, 1992
THROMBO-CALIBRATOR KIT
American Bioproducts Co.
Hematology
82d
Cleared
Mar 04, 1992
COAGULATION ARPR,CAT.NO.5185
Helena Laboratories
Hematology
121d
Cleared
Aug 22, 1991
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
Helena Laboratories
Hematology
142d
Cleared
Feb 11, 1991
AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183
Helena Laboratories
Hematology
55d
Cleared
Jul 26, 1990
COAGULATION CONTROL, LEVEL I
Sigma Chemical Co.
Hematology
58d
Cleared
Jul 26, 1990
COAGULATION CONTROL, LEVEL II
Sigma Chemical Co.
Hematology
58d