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

    Aptima BV Assay

    K Number: K190452 · Decision May 23, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    10
    Applicant Total
    116
    Review Days
    87

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    Basic Information

    Device Name
    Aptima BV Assay
    K Number
    K190452
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3975
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hologic, Inc.
    Date Received
    February 25, 2019
    Decision Date
    May 23, 2019
    Product Code
    PQA
    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
    PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

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