GJT · Class II · 21 CFR 864.7290

FDA Product Code GJT: Plasma, Coagulation Factor Deficient

Leading manufacturers include Instrumentation Laboratory CO, Sigma Chemical Co. and Helena Laboratories.

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 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 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 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

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.