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

    TruDiagnosis System

    K Number: K183530 · Decision May 24, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    156

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    Basic Information

    Device Name
    TruDiagnosis System
    K Number
    K183530
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3360
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Akonni Biosystems, Inc.
    Date Received
    December 19, 2018
    Decision Date
    May 24, 2019
    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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