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
73–79 of 79
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