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 Nov 01, 1999
IL TEST VON WILLEBRAND FACTOR
K992704
Instrumentation Laboratory CO
Hematology · 81d
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 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 Aug 19, 1997
ASSERACHROM TPA TEST KIT
K971519
American Bioproducts Co.
Hematology · 116d
Cleared Jul 25, 1997
VON WILLEBRAND REAGENT
K972116
Behring Diagnostics, Inc.
Hematology · 50d
Cleared Apr 21, 1997
HUMAN PROTEIN S RID TEST KIT
K951640
The Binding Site, Ltd.
Hematology · 742d
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 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
Cleared Feb 29, 1996
BIOCLOT PROTEIN S
K955738
Medical Diagnostic Technologies, Inc.
Hematology · 76d
Cleared Feb 09, 1996
CHROM Z-F:VIII, CAT. NO. 5241
K952668
Helena Laboratories
Hematology · 242d
Cleared Jan 30, 1996
CHROM Z-PROTEIN C, CAT. NO. 5243
K952666
Helena Laboratories
Hematology · 232d
Cleared Dec 07, 1995
CHROM Z-PLASMINOGEN, CAT. NO. 5244
K952669
Helena Laboratories
Hematology · 178d
Cleared Nov 13, 1995
ASSERACHROM FREE PROTEIN S KIT
K954017
American Bioproducts Co.
Hematology · 80d
Cleared Nov 13, 1995
ASSERACHROM TOTAL PROTEIN S KIT
K954040
American Bioproducts Co.
Hematology · 77d
Cleared Jan 24, 1995
PROTEIN C REAGENT, COAGULOMETRIC
K924425
Behring Diagnostics, Inc.
Hematology · 875d
Cleared Dec 22, 1994
HEMOLAB PROTEIN C CHROMOGENIC ASSAY
K934210
Biomerieux Vitek, Inc.
Hematology · 479d
Cleared Jan 27, 1994
MDA PROTEIN ASSAY
K925617
Organon Teknika Corp.
Hematology · 447d