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
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Plasma, Coagulation Factor Deficient Devices (Product Code GJT)

79 devices
1–24 of 79
Cleared Sep 13, 2023
CRYOcheck Factor VIII Deficient Plasma with VWF
K222831
Precision Biologic, Inc.
Hematology · 359d
Cleared Mar 22, 2018
HemosIL Factor XII Deficient Plasma
K180486
Instrumentation Laboratory CO
Hematology · 27d
Cleared Jul 08, 2011
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K110237
Instrumentation Laboratory CO
Hematology · 163d
Cleared May 02, 2005
HEMOSIL FACTOR II DEFICIENT PLASMA
K050661
Instrumentation Laboratory CO
Hematology · 48d
Cleared Feb 09, 2005
HEMOSIL FACTOR XII DEFICIENT PLASMA
K043459
Instrumentation Laboratory CO
Hematology · 56d
Cleared Feb 13, 2004
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K034007
Instrumentation Laboratory CO
Hematology · 51d
Cleared Jul 31, 2003
HEMOSIL FACTOR IX DEFICIENT PLASMA
K031829
Instrumentation Laboratory CO
Hematology · 48d
Cleared May 19, 2003
HEMOSIL FACTOR X DEFICIENT PLASMA
K031122
Instrumentation Laboratory CO
Hematology · 41d
Cleared Mar 19, 2003
HEMOSIL FACTOR XI DEFICIENT PLASMA
K030287
Instrumentation Laboratory CO
Hematology · 50d
Cleared Feb 12, 2003
HEMOSIL FACTOR VII DEFICIENT PLASMA
K024082
Instrumentation Laboratory CO
Hematology · 63d
Cleared Jan 14, 2003
HEMOSIL FACTOR V DEFICIENT PLASMA
K023839
Instrumentation Laboratory CO
Hematology · 57d
Cleared Oct 13, 1998
COAGULATION FACTOR V DEFICIENT PLASMA
K981709
Dade Behring, Inc.
Hematology · 162d
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 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

About Product Code GJT - Regulatory Context

510(k) Submission Activity

79 total 510(k) submissions under product code GJT since 1988, with 79 receiving FDA clearance (average review time: 116 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.