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

    Aptima BV Assay; Aptima CV/TV Assay

    K Number: K243345 · Decision Nov 25, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    10
    Applicant Total
    116
    Review Days
    28

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    Basic Information

    Device Name
    Aptima BV Assay; Aptima CV/TV Assay
    K Number
    K243345
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3975
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hologic, Inc.
    Date Received
    October 28, 2024
    Decision Date
    November 25, 2024
    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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