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
145–168 of 190
Cleared May 20, 1986
VWF-IX:AG CONTROL PLASMA
K861217
American Bioproducts Co.
Hematology · 50d
Cleared May 16, 1986
PROTEIN C CONTROL PLASMA
K861216
American Bioproducts Co.
Hematology · 46d
Cleared May 01, 1986
SPECTRO VWF
K861159
Ramco Laboratories, Inc.
Hematology · 34d
Cleared Apr 04, 1986
ASSERACHROM VWF KIT
K860371
American Bioproducts Co.
Hematology · 60d
Cleared Feb 04, 1986
ASSERACHROM IX:AG
K854312
American Bioproducts Co.
Hematology · 99d
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 Jul 19, 1984
MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII
K841708
Meloy Laboratories, Inc.
Hematology · 87d
Cleared Jul 19, 1984
BOVINE FACTOR XA-HUMAN FACTOR XA
K841957
Haemachem, Inc.
Hematology · 66d
Cleared May 02, 1984
COAGULATION CONTROL PLASMA LEVEL 1/2/3
K841461
Diatech, Inc.
Hematology · 23d
Cleared Apr 30, 1984
FACTOR DEFICIENT SUBSTRATE PLASMA II
K840927
Diatech, Inc.
Hematology · 59d
Cleared Apr 30, 1984
FACTOR DEFICIENT SUBSTRATE PLASMA VIII
K840928
Diatech, Inc.
Hematology · 59d
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 Feb 04, 1984
COAGULATION FACTOR DEFICIENT PLASMA
K840114
Medical Specialties Laboratories
Hematology · 24d
Cleared Jan 30, 1984
COATEST FACTOR VIII
K833892
Kabivitrum, Inc.
Hematology · 82d