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

    COPALIS EBV-M ANTIBODY ASSAY

    K Number: K991459 · Decision May 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    71
    Review Days
    18

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    Basic Information

    Device Name
    COPALIS EBV-M ANTIBODY ASSAY
    K Number
    K991459
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DiaSorin, Inc.
    Date Received
    April 26, 1999
    Decision Date
    May 14, 1999
    Product Code
    LJN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJN Antibody Igm, If, Epstein-Barr Virus

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