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
169–190 of 190
Cleared Dec 16, 1983
FACTOR II DEFICIENT SUBSTRATE PLASMA
K834031
Helena Laboratories
Hematology · 24d
Cleared Sep 29, 1983
DIACROM * FACTOR X KIT HA31
K832372
Wellcome Diagnostics
Chemistry · 73d
Cleared Aug 26, 1983
COATEST FACTOR X
K832114
Kabivitrum, Inc.
Hematology · 57d
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 Jul 27, 1982
EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.
K821963
Intl. Immunoassay Laboratories, Inc.
Hematology · 26d
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
Cleared Dec 31, 1979
HELENA FACTOR X DEFICIENT SUBSTRATE
K792508
Helena Laboratories
Hematology · 27d
Cleared Dec 31, 1979
HELENA FACTOR VII DEFICIENT SUB. PLASMA
K792511
Helena Laboratories
Hematology · 26d
Cleared Dec 27, 1979
HELENA FACTOR II DEFICIENT SUB. PLASMA
K792336
Helena Laboratories
Hematology · 38d
Cleared Dec 04, 1979
HELENA FACTOR VIII DEFICIENT SUB. PLASMA
K792335
Helena Laboratories
Hematology · 15d
Cleared Oct 01, 1979
FACTOR VII DEFICIENT PLASMA
K791794
Sigma Chemical Co.
Hematology · 18d
Cleared Apr 04, 1979
FACTOR V DEFICIENT
K790423
Sigma Chemical Co.
Hematology · 34d
Cleared Feb 07, 1977
QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT
K761058
Bio/Data Corp.
Hematology · 81d