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

    INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN

    K Number: K073014 · Decision Jan 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN
    K Number
    K073014
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.3360
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Autogenomics, Incorporated
    Date Received
    October 25, 2007
    Decision Date
    January 23, 2008
    Product Code
    ODW
    Advisory Committee
    Clinical Toxicology
    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
    ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

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    Other Clearances by Autogenomics, Incorporated

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