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

    LIAISON PLEX Gram-Positive Blood Culture Assay

    K Number: K243490 · Decision Jun 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    15
    Review Days
    206

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    Basic Information

    Device Name
    LIAISON PLEX Gram-Positive Blood Culture Assay
    K Number
    K243490
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3365
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Luminex Corporation
    Date Received
    November 12, 2024
    Decision Date
    June 6, 2025
    Product Code
    PAM
    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
    PAM Gram-Positive Bacteria And Their Resistance Markers

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