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 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
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 Jan 11, 1995
RISTOCETIN COFACTOR ASSAY KIT
K945414
Chrono-Log Corp.
Hematology · 65d
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