BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MycoMEIA Aspergillus Assay

    K Number: K243496 · Decision Aug 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    262

    Basic Information

    Device Name
    MycoMEIA Aspergillus Assay
    K Number
    K243496
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3040
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pearl Diagnostics, Inc.
    Date Received
    November 12, 2024
    Decision Date
    August 1, 2025
    Product Code
    NOM
    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
    NOM Antigen, Galactomannan, Aspergillus Spp.

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