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
97–120 of 190
Cleared Apr 17, 1992
RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA
K920981
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jan 15, 1992
DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY
K914818
Baxter Diagnostics, Inc.
Hematology · 82d
Cleared Jan 06, 1992
PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES
K915163
Biopool AB
Hematology · 53d
Cleared Dec 09, 1991
SPECTROLYSE PROTEIN C KIT
K914307
Biopool AB
Hematology · 75d
Cleared Oct 09, 1991
IL TEST PROCLOT ASSAY STYSTEM
K912711
Instrumentation Laboratory CO
Hematology · 112d
Cleared Oct 08, 1991
STACLOT(R) PROTEIN S TEST KIT
K913424
American Bioproducts Co.
Hematology · 68d
Cleared Oct 02, 1991
LIATEST PROTEIN S KIT
K912468
American Bioproducts Co.
Hematology · 120d
Cleared Aug 22, 1991
SPECTROLYSE PLASMINOGEN SK KIT
K912025
Biopool AB
Hematology · 107d
Cleared Feb 26, 1991
DADE PROTEIN C CLOTTING ASSAY
K903468
Baxter Healthcare Corp
Hematology · 209d
Cleared Jan 18, 1991
FREE PROTEIN S REAGENT CAT. NO. 5363
K904247
Helena Laboratories
Hematology · 126d
Cleared Aug 09, 1990
BIOCLOT C KIT
K902528
Biopool AB
Hematology · 65d
Cleared Aug 09, 1990
BIOPOOL PROTEIN C EID KIT AND BULK PLATES
K902566
Biopool AB
Hematology · 59d
Cleared Mar 15, 1990
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
K896174
Helena Laboratories
Hematology · 141d
Cleared Mar 15, 1990
ORTHOKROME* FACTOR VIII
K900395
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* ANTIPLASMIN
K900397
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* PROTEIN C
K900398
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* PLASMINOGEN
K900399
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Feb 05, 1990
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
K897136
Helena Laboratories
Hematology · 40d
Cleared Jun 23, 1989
THE STAGO VIII DEFICIENT PLASMA KIT
K892859
American Bioproducts Co.
Hematology · 66d
Cleared Apr 21, 1989
BERICHROM ALPHA-2-ANTIPLASMIN
K884797
Behring Diagnostics, Inc.
Hematology · 156d
Cleared Apr 21, 1989
BERICHROM PROTEIN C KIT
K890634
Behring Diagnostics, Inc.
Hematology · 72d
Cleared Mar 13, 1989
RELLPLATE C KIT, RELLPLATE C BULK PLATES
K884940
American Diagnostic Corp.
Hematology · 105d
Cleared Mar 13, 1989
ACTICLOT C KIT
K884941
American Diagnostic Corp.
Hematology · 105d
Cleared Feb 27, 1989
DADE(R) PLASMINOGEN CHROMOGENIC ASSAY
K890409
Baxter Healthcare Corp
Hematology · 34d