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

    BD MAX CT/GC/TV, BD MAX INSTRUMENT

    K Number: K151589 · Decision Sep 6, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    9
    Applicant Total
    134
    Review Days
    452

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    Basic Information

    Device Name
    BD MAX CT/GC/TV, BD MAX INSTRUMENT
    K Number
    K151589
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3860
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company
    Date Received
    June 12, 2015
    Decision Date
    September 6, 2016
    Product Code
    OUY
    Advisory Committee
    Immunology
    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
    OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System

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