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

    EBV IGG ELISA TEST

    K Number: K910872 · Decision Apr 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    57
    Review Days
    42

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    Basic Information

    Device Name
    EBV IGG ELISA TEST
    K Number
    K910872
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Gull Laboratories, Inc.
    Date Received
    March 1, 1991
    Decision Date
    April 12, 1991
    Product Code
    MCD
    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
    MCD Antigen, Ebv, Capsid

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