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

    Alinity m CMV

    K Number: K243485 · Decision Jul 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    2
    Applicant Total
    17
    Review Days
    235

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    Basic Information

    Device Name
    Alinity m CMV
    K Number
    K243485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3180
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Molecular, Inc.
    Date Received
    November 8, 2024
    Decision Date
    July 1, 2025
    Product Code
    PAB
    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
    PAB Cytomegalovirus (Cmv) Dna Quantitative Assay

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