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

    LIAISON MeMed BV, LIAISON MeMed BV Control Set

    K Number: K213936 · Decision Jul 14, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    71
    Review Days
    210

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    Basic Information

    Device Name
    LIAISON MeMed BV, LIAISON MeMed BV Control Set
    K Number
    K213936
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3215
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DiaSorin, Inc.
    Date Received
    December 16, 2021
    Decision Date
    July 14, 2022
    Product Code
    QPS
    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
    QPS Immunoassay For Host Biomarkers Of Infection

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