BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VIRGO (R) CMV-IGG ELISA

    K Number: K883102 · Decision Feb 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    17
    Applicant Total
    9
    Review Days
    201

    Basic Information

    Device Name
    VIRGO (R) CMV-IGG ELISA
    K Number
    K883102
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    ELECTRO-NUCLEONICS, INC.
    Date Received
    July 22, 1988
    Decision Date
    February 8, 1989
    Product Code
    GQI
    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
    GQI Antiserum, Cf, Cytomegalovirus

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