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

    INFINITI CYP2C19 ASSAY

    K Number: K101683 · Decision Oct 25, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    132

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    Basic Information

    Device Name
    INFINITI CYP2C19 ASSAY
    K Number
    K101683
    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
    June 15, 2010
    Decision Date
    October 25, 2010
    Product Code
    NTI
    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
    NTI Drug Metabolizing Enzyme Genotyping Systems

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    Other Clearances by Autogenomics, Incorporated

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    K073014 INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN