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

    BARTELS EPSTEIN-BARR VIRUS IGM EIA

    K Number: K922331 · Decision Sep 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    72
    Review Days
    112

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    Basic Information

    Device Name
    BARTELS EPSTEIN-BARR VIRUS IGM EIA
    K Number
    K922331
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    May 13, 1992
    Decision Date
    September 2, 1992
    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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