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
49–72 of 190
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
Cleared Aug 13, 1997
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT
K972005
Reaads Medical Products, Inc.
Hematology · 75d
Cleared Aug 13, 1997
REAADS PROTEIN S ANTIGEN TEST KIT
K972482
Reaads Medical Products, Inc.
Hematology · 42d
Cleared Jul 25, 1997
VON WILLEBRAND REAGENT
K972116
Behring Diagnostics, Inc.
Hematology · 50d
Cleared Jul 14, 1997
FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
K972288
Universal Reagents, Inc.
Hematology · 25d
Cleared Apr 21, 1997
HUMAN PROTEIN S RID TEST KIT
K951640
The Binding Site, Ltd.
Hematology · 742d
Cleared Dec 18, 1996
UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
K964270
Universal Reagents, Inc.
Hematology · 54d
Cleared Dec 18, 1996
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
K964459
Universal Reagents, Inc.
Hematology · 41d
Cleared Dec 13, 1996
PROC APC ASSAY, PROC CONTROL PLASMA
K962968
Behring Diagnostics, Inc.
Hematology · 136d
Cleared Nov 18, 1996
CHROMOLIZE PAI-1 KIT
K963106
Medical Diagnostic Technologies, Inc.
Hematology · 98d
Cleared Nov 15, 1996
SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY
K962825
Shield Diagnostics, Ltd.
Hematology · 119d
Cleared Oct 10, 1996
FACTOR DEFICIENT PLASMA
K961929
Universal Reagents, Inc.
Hematology · 146d
Cleared Jul 31, 1996
CHROMOLIZE TPA ASSAY KIT
K962489
Medical Diagnostic Technologies, Inc.
Hematology · 35d
Cleared Jun 05, 1996
TINTELIZE PAI-1 KIT
K960438
Medical Diagnostic Technologies, Inc.
Hematology · 126d
Cleared Feb 29, 1996
AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II
K952126
Aalto Scientific, Ltd.
Hematology · 297d