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
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 Jun 07, 1999
CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
K990814
Precision Biologic
Hematology · 88d
Cleared Mar 18, 1999
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
K990296
Precision Biologic
Hematology · 49d
Cleared Feb 17, 1999
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
K990046
Pacific Hemostasis
Hematology · 41d
Cleared Jan 13, 1999
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
K981173
Precision Biologicals, Inc.
Hematology · 287d
Cleared Jan 13, 1999
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
K981174
Precision Biologicals, Inc.
Hematology · 287d
Cleared Oct 13, 1998
COAGULATION FACTOR V DEFICIENT PLASMA
K981709
Dade Behring, Inc.
Hematology · 162d
Cleared Aug 13, 1997
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)
K972627
Pacific Hemostasis
Hematology · 30d
Cleared Jul 22, 1997
CRYO CHECK FACTOR V DEFICIENT PLASMA
K971223
Precision Biologicals, Inc.
Hematology · 111d
Cleared Jul 18, 1997
CRYO CHECK FACTOR IX DEFICIENT PLASMA
K971226
Precision Biologicals, Inc.
Hematology · 107d
Cleared Jul 18, 1997
CRYO CHECK FACTOR X DEFICIENT PLASMA
K971227
Precision Biologicals, Inc.
Hematology · 107d
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

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.