GJT · Class II · 21 CFR 864.7290

FDA Product Code GJT: Plasma, Coagulation Factor Deficient

Leading manufacturers include Instrumentation Laboratory CO, Medical Diagnostic Technologies, Inc. and American Bioproducts Co..

79
Total
79
Cleared
116d
Avg days
1988
Since
79 devices
49–72 of 79
Cleared Jun 23, 1989
FACTOR X DEFICIENT PLASMA
K893523
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR IX DEFICIENT PLASMA
K893524
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR VIII DEFICIENT PLASMA
K893525
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR V DEFICIENT PLASMA
K893533
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR XII DEFICIENT PLASMA
K893534
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR VII DEFICIENT PLASMA
K893535
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR XI DEFICIENT PLASMA
K893536
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Nov 01, 1988
ORTHO FACTOR XII DEFICIENT PLASMA
K883688
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO FACTOR X DEFICIENT PLASMA
K883690
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO FACTOR XI DEFICIENT PLASMA
K883691
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO FACTOR VII DEFICIENT PLASMA
K883692
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Mar 17, 1988
IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN
K880874
Baxter Healthcare Corp
Hematology · 16d
Cleared Feb 19, 1988
FACTOR VIII REFERENCE PLASMA
K880292
Helena Laboratories
Hematology · 25d