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
25–48 of 79
Cleared Jul 17, 1997
CRYO CHECK FACTOR VII DEFICIENT PLASMA
K971224
Precision Biologicals, Inc.
Hematology · 106d
Cleared Jul 17, 1997
CRYO CHECK FACTOR VIII DEFICIENT PLASMA
K971225
Precision Biologicals, Inc.
Hematology · 106d
Cleared Jul 14, 1997
FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
K972286
Universal Reagents, Inc.
Hematology · 25d
Cleared Apr 25, 1997
UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
K970593
Universal Reagents, Inc.
Hematology · 66d
Cleared Apr 25, 1997
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
K970607
Universal Reagents, Inc.
Hematology · 66d
Cleared Oct 25, 1996
STA - LIATEST VWF TEST KIT
K962675
American Bioproducts Co.
Hematology · 108d
Cleared Sep 13, 1996
STA-VWF CALIBRATOR KIT
K962671
American Bioproducts Co.
Hematology · 66d
Cleared Oct 20, 1995
PROTEIN C DEFICIENT PLASMA
K945857
George King Bio-Medical, Inc.
Hematology · 340d
Cleared May 19, 1995
BIOMERIEUX HEMOLAB COFAC II
K942049
Biomerieux Vitek, Inc.
Hematology · 386d
Cleared May 19, 1995
HEMOLAB COFAC IX
K942050
Biomerieux Vitek, Inc.
Hematology · 386d
Cleared Jan 17, 1995
BIOMERIEUX HEMOLAB COFAC VII
K935850
Biomerieux Vitek, Inc.
Hematology · 405d
Cleared Jan 17, 1995
BIOMERIEUX HEMOLAB COFAC X
K935851
Biomerieux Vitek, Inc.
Hematology · 405d
Cleared Mar 15, 1994
FACTOR VIII DEFICIENT PLASMA
K935057
Sigma Diagnostics, Inc.
Hematology · 145d
Cleared Mar 07, 1994
FACTOR X DEFICIENT PLASMA
K935054
Sigma Diagnostics, Inc.
Hematology · 137d
Cleared Mar 07, 1994
FACTOR VII DEFICIENT PLASMA
K935056
Sigma Diagnostics, Inc.
Hematology · 137d
Cleared Mar 07, 1994
FACTOR
K935058
Sigma Diagnostics, Inc.
Hematology · 137d
Cleared Mar 01, 1994
STAGO FACTOR V-DEFICIENT PLASMA
K934605
American Bioproducts Co.
Hematology · 155d
Cleared Mar 01, 1994
STAGO FACTOR II-DEFICIENT PLASMA
K934606
American Bioproducts Co.
Hematology · 155d
Cleared Nov 15, 1993
STAGO FACTOR IX-DEFICIENT PLASMA
K933432
American Bioproducts Co.
Hematology · 124d
Cleared Oct 27, 1993
STAGO FACTOR XII-DEFICIENT PLASMA
K933438
American Bioproducts Co.
Hematology · 105d
Cleared Oct 27, 1993
STAGO FACTOR VII-DEFICIENT PLASMA
K933440
American Bioproducts Co.
Hematology · 105d
Cleared Oct 27, 1993
STAGO FACTOR X-DEFICIENT PLASMA
K933441
American Bioproducts Co.
Hematology · 105d
Cleared Oct 27, 1993
STAGO FACTOR XI-DEFICIENT PLASMA
K933444
American Bioproducts Co.
Hematology · 105d
Cleared Sep 15, 1993
BIOMERIEUX HEMOLAB COFAC VIII
K933010
Biomerieux Vitek, Inc.
Hematology · 86d