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

    IS EBV-EBNA-1 IGG ELISA TEST SYSTEM

    K Number: K981829 · Decision Feb 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    19
    Applicant Total
    68
    Review Days
    270

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    Basic Information

    Device Name
    IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
    K Number
    K981829
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diamedix Corp.
    Date Received
    May 22, 1998
    Decision Date
    February 16, 1999
    Product Code
    GNP
    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
    GNP Antiserum, Cf, Epstein-Barr Virus

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