Product code GJT— Hematology
FACTOR VII DEFICIENT PLASMA
- Classification name
- Plasma, Coagulation Factor Deficient
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Total cleared
- 79
- First cleared
- Most recent
Market context for product code GJT
FDA has cleared devices under product code GJT between 1988 and 2023, filed by 20 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2023
- 2018
- 2011
- 2005
- 2004
- 2003
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
Top applicants under product code GJT
Recent clearances under product code GJT
- K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF
- K180486 — HemosIL Factor XII Deficient Plasma
- K102851 — NOFACT VIII
- K102908 — NOFACT IX
- K110237 — HEMOSIL FACTOR VIII DEFICIENT PLASMA
- K050661 — HEMOSIL FACTOR II DEFICIENT PLASMA
- K043459 — HEMOSIL FACTOR XII DEFICIENT PLASMA
- K040362 — DIAPHARMA FACTOR X KIT
- K034007 — HEMOSIL FACTOR VIII DEFICIENT PLASMA
- K031829 — HEMOSIL FACTOR IX DEFICIENT PLASMA
- K031122 — HEMOSIL FACTOR X DEFICIENT PLASMA
- K030287 — HEMOSIL FACTOR XI DEFICIENT PLASMA
- K024082 — HEMOSIL FACTOR VII DEFICIENT PLASMA
- K023839 — HEMOSIL FACTOR V DEFICIENT PLASMA
- K990814 — CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
- K990296 — CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
- K990046 — PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
- K981173 — CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
- K981174 — CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
- K981709 — COAGULATION FACTOR V DEFICIENT PLASMA
- K972627 — PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)
- K971223 — CRYO CHECK FACTOR V DEFICIENT PLASMA
- K971226 — CRYO CHECK FACTOR IX DEFICIENT PLASMA
- K971227 — CRYO CHECK FACTOR X DEFICIENT PLASMA
- K971224 — CRYO CHECK FACTOR VII DEFICIENT PLASMA
- K971225 — CRYO CHECK FACTOR VIII DEFICIENT PLASMA
- K972286 — FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
- K970593 — UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
- K970607 — UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
- K962675 — STA - LIATEST VWF TEST KIT
- K962671 — STA-VWF CALIBRATOR KIT
- K945857 — PROTEIN C DEFICIENT PLASMA
- K942049 — BIOMERIEUX HEMOLAB COFAC II
- K942050 — HEMOLAB COFAC IX
- K935850 — BIOMERIEUX HEMOLAB COFAC VII
- K935851 — BIOMERIEUX HEMOLAB COFAC X
- K935057 — FACTOR VIII DEFICIENT PLASMA
- K935054 — FACTOR X DEFICIENT PLASMA
- K935056 — FACTOR VII DEFICIENT PLASMA
- K935058 — FACTOR
- K934605 — STAGO FACTOR V-DEFICIENT PLASMA
- K934606 — STAGO FACTOR II-DEFICIENT PLASMA
- K933432 — STAGO FACTOR IX-DEFICIENT PLASMA
- K933438 — STAGO FACTOR XII-DEFICIENT PLASMA
- K933440 — STAGO FACTOR VII-DEFICIENT PLASMA
- K933441 — STAGO FACTOR X-DEFICIENT PLASMA
- K933444 — STAGO FACTOR XI-DEFICIENT PLASMA
- K933010 — BIOMERIEUX HEMOLAB COFAC VIII
- K924400 — CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA
- K924396 — CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
- K924394 — CLOTTING FACTOR V DEFICIENT PLASMA
- K915411 — DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA
- K912679 — DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
- K902083 — CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE
- K901327 — ORTHO CORRECTION REAGENTS
- K900406 — FACTOR V DEFICIENT PLASMA
- K900407 — FACTOR VII DEFICIENT PLASMA
- K900408 — FACTOR VIII DEFICIENT PLASMA
- K900409 — FACTOR IX DEFICIENT PLASMA
- K900410 — FACTOR X DEFICIENT PLASMA
- K900411 — FACTOR XI DEFICIENT PLASMA
- K900412 — FACTOR XII DEFICIENT PLASMA
- K900906 — FACTOR II DEFICIENT PLASMA
- K900133 — FACTOR II DEFICIENT PLASMA
- K895503 — ABNORMAL REFERENCE PLASMA-VIII
- K895504 — ABNORMAL REFERENCE PLASMA-IX
- K893523 — FACTOR X DEFICIENT PLASMA
- K893524 — FACTOR IX DEFICIENT PLASMA
- K893525 — FACTOR VIII DEFICIENT PLASMA
- K893533 — FACTOR V DEFICIENT PLASMA
- K893534 — FACTOR XII DEFICIENT PLASMA
- K893535 — FACTOR VII DEFICIENT PLASMA
- K893536 — FACTOR XI DEFICIENT PLASMA
- K883688 — ORTHO FACTOR XII DEFICIENT PLASMA
- K883690 — ORTHO FACTOR X DEFICIENT PLASMA
- K883691 — ORTHO FACTOR XI DEFICIENT PLASMA
- K883692 — ORTHO FACTOR VII DEFICIENT PLASMA
- K880874 — IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN
- K880292 — FACTOR VIII REFERENCE PLASMA
Data sourced from openFDA. This site is unofficial and independent of the FDA.