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
49–72 of 79
Cleared Jun 08, 1993
CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA
K924400
Behring Diagnostics, Inc.
Hematology · 281d
Cleared May 21, 1993
CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
K924396
Behring Diagnostics, Inc.
Hematology · 263d
Cleared Dec 01, 1992
CLOTTING FACTOR V DEFICIENT PLASMA
K924394
Behring Diagnostics, Inc.
Hematology · 92d
Cleared May 11, 1992
DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA
K915411
Baxter Diagnostics, Inc.
Hematology · 161d
Cleared Sep 10, 1991
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
K912679
Baxter Healthcare Corp
Hematology · 84d
Cleared Jun 15, 1990
CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE
K902083
Helena Laboratories
Hematology · 39d
Cleared May 25, 1990
ORTHO CORRECTION REAGENTS
K901327
Ortho Diagnostic Systems, Inc.
Hematology · 65d
Cleared Mar 06, 1990
FACTOR V DEFICIENT PLASMA
K900406
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR VII DEFICIENT PLASMA
K900407
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR VIII DEFICIENT PLASMA
K900408
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR IX DEFICIENT PLASMA
K900409
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR X DEFICIENT PLASMA
K900410
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR XI DEFICIENT PLASMA
K900411
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR XII DEFICIENT PLASMA
K900412
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR II DEFICIENT PLASMA
K900906
Sigma Chemical Co.
Hematology · 7d
Cleared Jan 25, 1990
FACTOR II DEFICIENT PLASMA
K900133
Medical Diagnostic Technologies, Inc.
Hematology · 15d
Cleared Oct 06, 1989
ABNORMAL REFERENCE PLASMA-VIII
K895503
Medical Diagnostic Technologies, Inc.
Hematology · 24d
Cleared Oct 06, 1989
ABNORMAL REFERENCE PLASMA-IX
K895504
Medical Diagnostic Technologies, Inc.
Hematology · 24d
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