BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    NG-Test® CTX-M MULTI

    K Number: K243499 · Decision Jun 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    204

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    Basic Information

    Device Name
    NG-Test® CTX-M MULTI
    K Number
    K243499
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ng Biotech
    Date Received
    November 12, 2024
    Decision Date
    June 4, 2025
    Product Code
    PTJ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PTJ Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

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