GGP · Test, Qualitative And Quantitative Factor Deficiency

Hematology · 21 CFR 864.7290 · Class 2

Overview

Product CodeGGP
Device NameTest, Qualitative And Quantitative Factor Deficiency
Regulation21 CFR 864.7290
Device ClassClass 2
Review PanelHematology
3rd-Party ReviewableYes

Recent Cleared Devices (20 of 190)

Showing 20 most recent of 190 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.Aug 25, 2025SESE
K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyDec 13, 2023SESE
K220728vWF AgSiemens Healthcare Diagnostics Products GmbHJun 2, 2023SESE
K214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.Dec 23, 2022SESE
K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CODec 9, 2022SESE
K200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COAug 19, 2020SESE
K193204Cryocheck Chromogenic Factor VIIIPrecision BiologicJul 17, 2020SESE
K183440CRYOcheck FVIII Inhibitor KitPrecision Biologic, Inc.Mar 12, 2019SESE
K181525INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbHSep 7, 2018SESE
K133005HEMOSIL VON WILLEBRAND ACTIVITY ASSAYInstrumentation Laboratory COMar 13, 2014SESE
K102164HEMOSIL PROTEIN S ACTIVITY ASSAYInstrumentation Laboratory COMar 17, 2011SESE
K092170STA LIATEST FREE PSDiagnostica Stago, Inc.Dec 22, 2009SESE
K082631THROMBO TEK PSE, MODEL 90-480R2 Diagnostics, Inc.Dec 17, 2008SESE
K082205FACTOR VIII ANTIBODY SCREENGenetic Testing InstituteNov 20, 2008SESE
K063323SPECTROLYSE PAI-1, MODEL 101201American Diagnostica, Inc.Aug 15, 2007SESE
K070635HEMOSIL PROCLOTInstrumentation Laboratory COMar 29, 2007SESE
K062530TRIAGE PROTEIN C TESTBiosite IncorporatedJan 29, 2007SESE
K062430HEMOSIL PROTEIN CInstrumentation Laboratory COSep 1, 2006SESE
K052825VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AGAffinity Biologicals, Inc.Jan 20, 2006SESE
K053499HEMOSIL PROSInstrumentation Laboratory COJan 13, 2006SESE

Top Applicants

Innolitics

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