BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

    K Number: K071867 · Decision Apr 28, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    297

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    Basic Information

    Device Name
    RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA
    K Number
    K071867
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7750
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Paragondx, LLC
    Date Received
    July 6, 2007
    Decision Date
    April 28, 2008
    Product Code
    ODV
    Advisory Committee
    Hematology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ODV Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System