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 Jan 03, 1986
ASSERA PLATE IX:AG KIT
K854014
American Bioproducts Co.
Hematology · 98d
Cleared Aug 29, 1985
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
K853461
American Dade
Hematology · 10d
Cleared Aug 29, 1985
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
K853462
American Dade
Hematology · 10d
Cleared Nov 19, 1984
FACTOR IX DEFICIENT PLASMA, B9D -
K843215
Sigma Chemical Co.
Hematology · 96d
Cleared Nov 19, 1984
FACTOR X DEFICIENT PLASMA, BLOD HUMAN
K843310
Sigma Chemical Co.
Hematology · 88d
Cleared Nov 19, 1984
FACTOR XI DEFICIENT PLASMA B11D
K843438
Sigma Chemical Co.
Hematology · 76d
Cleared Nov 19, 1984
FACTOR XII DEFICIENT PLASMA B12D
K843451
Sigma Chemical Co.
Hematology · 75d
Cleared Oct 01, 1984
VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT
K842617
American Dade
Hematology · 88d
Cleared Apr 25, 1984
COAGULATION FACTOR V DEFICIENT SUBSTR
K841364
American Dade
Hematology · 23d
Cleared Apr 05, 1984
RISTOCETIN COFACTOR ASSAY
K840329
Helena Laboratories
Hematology · 71d
Cleared Feb 04, 1984
PROTOPATH FACTOR IX ASSAY
K834050
American Dade
Hematology · 73d
Cleared Feb 04, 1984
PROTOPATH FACTOR VIII ASSAY
K834051
American Dade
Hematology · 73d
Cleared Dec 16, 1983
FACTOR II DEFICIENT SUBSTRATE PLASMA
K834031
Helena Laboratories
Hematology · 24d
Cleared Jan 21, 1983
VON WILLEBRAND FACTOR ASSAY
K823453
General Diagnostics
Hematology · 65d
Cleared Dec 28, 1982
FACTOR VIII RELATED ANTIGEN ROCKET EID
K823267
Helena Laboratories
Hematology · 56d
Cleared Feb 23, 1982
DADE FACTOR ASSAY REFERENCE PLASMA
K820085
American Dade
Hematology · 42d
Cleared Nov 16, 1981
LANCER COAGENT HUMAN FACTOR 1X PLASMA
K812974
Sherwood Medical Co.
Hematology · 24d
Cleared Nov 16, 1981
LANCER COAGENT HUMAN VACTOR VIII PLASMA
K812975
Sherwood Medical Co.
Hematology · 24d
Cleared Sep 23, 1981
FACTOR VIII DEFICIENT PLASMA #B8D
K812431
Sigma Chemical Co.
Hematology · 29d
Cleared Dec 01, 1980
VON WILLEBRAND FACTOR ASSAY
K802356
Bio/Data Corp.
Hematology · 66d
Cleared Jan 24, 1980
HELENA FACTOR XII DEFICIENT
K792656
Helena Laboratories
Hematology · 29d
Cleared Dec 31, 1979
HELENA FACTOR IX DEFICIENT SUBSTRATE
K792475
Helena Laboratories
Hematology · 28d
Cleared Dec 31, 1979
HELENA FACTOR XI DEFICIENT SUBSTRATE
K792476
Helena Laboratories
Hematology · 28d
Cleared Dec 31, 1979
HELENA FACTOR V DEFICIENT SUBSTRATE
K792507
Helena Laboratories
Hematology · 27d