Home / Device Classification / GJT

GJT — Plasma, Coagulation Factor Deficient Class II

FDA Device Classification

Classification Details

Product Code
GJT
Device Class
Class II
Regulation Number
864.7290
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222831precision biologicCRYOcheck Factor VIII Deficient Plasma with VWFSeptember 13, 2023
K180486instrumentation laboratoryHemosIL Factor XII Deficient PlasmaMarch 22, 2018
K102851r2 diagnosticsNOFACT VIIIDecember 19, 2011
K102908r2 diagnosticsNOFACT IXDecember 19, 2011
K110237instrumentation laboratoryHEMOSIL FACTOR VIII DEFICIENT PLASMAJuly 8, 2011
K050661instrumentation laboratoryHEMOSIL FACTOR II DEFICIENT PLASMAMay 2, 2005
K043459instrumentation laboratoryHEMOSIL FACTOR XII DEFICIENT PLASMAFebruary 9, 2005
K040362diapharma groupDIAPHARMA FACTOR X KITJuly 12, 2004
K034007instrumentation laboratoryHEMOSIL FACTOR VIII DEFICIENT PLASMAFebruary 13, 2004
K031829instrumentation laboratoryHEMOSIL FACTOR IX DEFICIENT PLASMAJuly 31, 2003
K031122instrumentation laboratoryHEMOSIL FACTOR X DEFICIENT PLASMAMay 19, 2003
K030287instrumentation laboratoryHEMOSIL FACTOR XI DEFICIENT PLASMAMarch 19, 2003
K024082instrumentation laboratoryHEMOSIL FACTOR VII DEFICIENT PLASMAFebruary 12, 2003
K023839instrumentation laboratoryHEMOSIL FACTOR V DEFICIENT PLASMAJanuary 14, 2003
K990814precision biologicCRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15June 7, 1999
K990296precision biologicCRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10March 18, 1999
K990046pacific hemostasisPACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMAFebruary 17, 1999
K981173precision biologicalsCRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5MJanuary 13, 1999
K981174precision biologicalsCRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5MJanuary 13, 1999
K981709dade behringCOAGULATION FACTOR V DEFICIENT PLASMAOctober 13, 1998