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

    Alinity m HSV 1 & 2 / VZV

    K Number: K233349 · Decision May 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    8
    Applicant Total
    17
    Review Days
    217

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    Basic Information

    Device Name
    Alinity m HSV 1 & 2 / VZV
    K Number
    K233349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3309
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Molecular, Inc.
    Date Received
    September 29, 2023
    Decision Date
    May 3, 2024
    Product Code
    PGI
    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
    PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

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