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GGP — Test, Qualitative And Quantitative Factor Deficiency Class II

FDA Device Classification

Classification Details

Product Code
GGP
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
K251440precision biologicCRYOcheck Chromogenic Factor VIIIAugust 25, 2025
K230852instrumentation laboratoryHemosIL Chromogenic Factor IXDecember 13, 2023
K220728siemens healthcare diagnostics productsvWF AgJune 2, 2023
K214002precision biologicCRYOcheck Chromogenic Factor IXDecember 23, 2022
K223402instrumentation laboratoryHemosIL von Willebrand Factor AntigenDecember 9, 2022
K200033instrumentation laboratoryHemosIL von Willebrand Factor AntigenAugust 19, 2020
K193204precision biologicCryocheck Chromogenic Factor VIIIJuly 17, 2020
K183440precision biologicCRYOcheck FVIII Inhibitor KitMarch 12, 2019
K181525siemens healthcare diagnostics productsINNOVANCE Free PS AgSeptember 7, 2018
K133005instrumentation laboratoryHEMOSIL VON WILLEBRAND ACTIVITY ASSAYMarch 13, 2014
K102164instrumentation laboratoryHEMOSIL PROTEIN S ACTIVITY ASSAYMarch 17, 2011
K092170diagnostica stagoSTA LIATEST FREE PSDecember 22, 2009
K082631r2 diagnosticsTHROMBO TEK PSE, MODEL 90-480December 17, 2008
K082205genetic testing instituteFACTOR VIII ANTIBODY SCREENNovember 20, 2008
K063323american diagnosticaSPECTROLYSE PAI-1, MODEL 101201August 15, 2007
K070635instrumentation laboratoryHEMOSIL PROCLOTMarch 29, 2007
K062530biosite incorporatedTRIAGE PROTEIN C TESTJanuary 29, 2007
K062430instrumentation laboratoryHEMOSIL PROTEIN CSeptember 1, 2006
K052825affinity biologicalsVISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AGJanuary 20, 2006
K053499instrumentation laboratoryHEMOSIL PROSJanuary 13, 2006