GGP · Class II · 21 CFR 864.7290

FDA Product Code GGP: Test, Qualitative And Quantitative Factor Deficiency

Leading manufacturers include Instrumentation Laboratory CO, American Bioproducts Co. and Helena Laboratories.

190
Total
190
Cleared
108d
Avg days
1977
Since
190 devices
25–48 of 190
Cleared Aug 27, 2002
PROTEIN S AC
K022290
Dade Behring, Inc.
Hematology · 43d
Cleared Jun 25, 2001
IL TEST PROS
K011424
Instrumentation Laboratory CO
Hematology · 47d
Cleared Jun 06, 2001
STA-LIATEST FREE PROTEIN S TEST KIT
K010963
Diagnostica Stago, Inc.
Hematology · 68d
Cleared Apr 13, 2001
IL TEST FREE PROTEIN S
K010379
Instrumentation Laboratory CO
Hematology · 64d
Cleared Oct 13, 2000
COALIZA PROTEIN S-FREE
K002467
Instrumentation Laboratory CO
Hematology · 63d
Cleared Sep 26, 2000
PROTEIN C REAGENT
K002541
Dade Behring, Inc.
Hematology · 41d
Cleared Apr 25, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K000649
Dade Behring, Inc.
Hematology · 57d
Cleared Apr 17, 2000
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
K000398
Shield Diagnostics, Ltd.
Hematology · 70d
Cleared Feb 01, 2000
GTI-FVIII INHIBITOR ASSAY
K993553
Genetic Testing Institute
Hematology · 104d
Cleared Nov 01, 1999
IL TEST VON WILLEBRAND FACTOR
K992704
Instrumentation Laboratory CO
Hematology · 81d
Cleared Jan 06, 1999
BIOCLOT APC SENSITIVITY
K983898
Biopool Intl., Inc.
Hematology · 64d
Cleared Dec 22, 1998
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
K983914
Corgenix, Inc.
Hematology · 48d
Cleared Oct 22, 1998
VFE
K983107
Ramco Laboratories, Inc.
Hematology · 48d
Cleared Sep 28, 1998
COAMATIC PLASMIN INHIBITOR
K981817
Instrumentation Laboratory CO
Hematology · 129d
Cleared Aug 27, 1998
IL TEST PLASMIN INHIBITOR
K981696
Instrumentation Laboratory CO
Hematology · 105d
Cleared Aug 21, 1998
SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY
K980885
Shield Diagnostics, Ltd.
Hematology · 165d
Cleared May 26, 1998
IL TEST PLASMINOGEN
K981200
Instrumentation Laboratory CO
Hematology · 54d
Cleared May 01, 1998
COAMATIC PLASMINOGEN
K974711
Instrumentation Laboratory CO
Hematology · 135d
Cleared Apr 21, 1998
IL TEST PROTEIN C
K980875
Instrumentation Laboratory CO
Hematology · 46d
Cleared Apr 16, 1998
COAMATIC FACTOR VIII
K981038
Instrumentation Laboratory CO
Hematology · 28d
Cleared Oct 20, 1997
N-ASSAY TIA PLASMINOGEN TEST KIT
K971985
Crestat Diagnostics, Inc.
Hematology · 144d
Cleared Oct 06, 1997
REAADS PROTEIN C ANTIGEN TEST KIT
K972342
Reaads Medical Products, Inc.
Hematology · 104d
Cleared Sep 25, 1997
UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA
K973143
Universal Reagents, Inc.
Hematology · 34d
Cleared Aug 19, 1997
ASSERACHROM TPA TEST KIT
K971519
American Bioproducts Co.
Hematology · 116d