GJT · Class II · 21 CFR 864.7290

FDA Product Code GJT: Plasma, Coagulation Factor Deficient

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

79
Total
79
Cleared
116d
Avg days
1988
Since
79 devices
73–79 of 79
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