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

    BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY

    K Number: K130268 · Decision Aug 23, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    9
    Applicant Total
    190
    Review Days
    200

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    Basic Information

    Device Name
    BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
    K Number
    K130268
    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 & CO
    Date Received
    February 4, 2013
    Decision Date
    August 23, 2013
    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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