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

    Aptima SARS-CoV-2 Assay

    K Number: K243396 · Decision Feb 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    10
    Applicant Total
    116
    Review Days
    105

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    Basic Information

    Device Name
    Aptima SARS-CoV-2 Assay
    K Number
    K243396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3981
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hologic, Inc.
    Date Received
    October 31, 2024
    Decision Date
    February 13, 2025
    Product Code
    QQX
    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
    QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

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