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
73–96 of 190
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 Nov 06, 1995
COAMATIC FACTOR VIII
K943225
Pharmacia Hepar, Inc.
Hematology · 488d
Cleared Sep 25, 1995
SPECTROLYSE ANTIPLASMIN KIT
K941752
Biopool AB
Hematology · 535d
Cleared Jul 13, 1995
BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES
K942087
Biopool AB
Hematology · 437d
Cleared Mar 06, 1995
HUMAN PROTEIN C RID TEST KIT
K950015
Jay H. Geller
Microbiology · 62d
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 Feb 23, 1994
TINTELIZER(R) TPA
K934314
Biopool AB
Hematology · 175d
Cleared Jan 27, 1994
MDA PROTEIN ASSAY
K925617
Organon Teknika Corp.
Hematology · 447d
Cleared Dec 06, 1993
SPECTROLYSE FACTOR VII:C
K934584
Meditech, Inc.
Hematology · 74d
Cleared Nov 05, 1993
NEW STACHROM PROTEIN C TEST KIT
K931906
American Bioproducts Co.
Hematology · 206d
Cleared Sep 02, 1993
HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY
K930235
Technidyne Corp.
Hematology · 240d
Cleared Apr 12, 1993
IL TEST(TM) PROTEIN S
K930327
Instrumentation Laboratory CO
Hematology · 80d
Cleared Jan 14, 1993
IL TEST(TM) PRO-CHROM
K924884
Instrumentation Laboratory CO
Hematology · 108d
Cleared Dec 07, 1992
COAMATE PROTEIN C CHROMOGENIC ASSAY
K922201
Chromogenix AB
Hematology · 210d
Cleared Oct 09, 1992
SPECTROLYSE/PL PAI KIT
K922782
Biopool AB
Hematology · 122d
Cleared Sep 23, 1992
NEW STACHROM ANTIPLASMIN
K921449
American Bioproducts Co.
Hematology · 181d
Cleared Aug 12, 1992
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM
K920012
Instrumentation Laboratory CO
Hematology · 223d