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 Dec 02, 2004
COATEST SP FVIII
K042576
Instrumentation Laboratory CO
Hematology · 71d
Cleared Jun 18, 2004
CRYOCHECK CLOT C
K040987
Precision Biologic, Inc.
Hematology · 64d
Cleared Apr 30, 2004
HEMOSIL VON WILLEBRAND ACTIVITY
K040843
Instrumentation Laboratory CO
Hematology · 29d
Cleared Apr 05, 2004
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
K032139
Corgenix, Inc.
Hematology · 269d
Cleared Dec 15, 2003
MODIFICATION TO COATEST FACTOR VIII
K033631
Instrumentation Laboratory CO
Hematology · 26d
Cleared Mar 19, 2003
CHROMOCHECK PROTEIN C 25
K023990
Precision Biologic
Hematology · 106d
Cleared Aug 27, 2002
PROTEIN S AC
K022290
Dade Behring, Inc.
Hematology · 43d
Cleared Mar 13, 2002
IMUBIND TPA ELISA, MODEL 860
K013492
American Diagnostica, Inc.
Hematology · 142d
Cleared Mar 07, 2002
IMUBIND PLASMA PAI-1 ELISA,MODEL 822
K013168
American Diagnostica, Inc.
Hematology · 167d
Cleared Sep 14, 2001
ACTICLOT PROTEIN S, MODEL 843L
K012386
American Diagnostica, Inc.
Hematology · 49d
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 Oct 05, 2000
REFACTO LABORATORY STANDARD
K002350
The Genetics Institute
Hematology · 64d
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