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

    AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST

    K Number: K911362 · Decision Oct 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    193

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    Basic Information

    Device Name
    AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST
    K Number
    K911362
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Amico Laboratories, Inc.
    Date Received
    March 28, 1991
    Decision Date
    October 7, 1991
    Product Code
    LJN
    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
    LJN Antibody Igm, If, Epstein-Barr Virus

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