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

    COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION

    K Number: K872576 · Decision Dec 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    18
    Applicant Total
    5
    Review Days
    157

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    Basic Information

    Device Name
    COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION
    K Number
    K872576
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Enzo Biochem, Inc.
    Date Received
    June 30, 1987
    Decision Date
    December 4, 1987
    Product Code
    GQH
    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
    GQH Antigen, Cf (Including Cf Control), Cytomegalovirus

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