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

    COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV

    K Number: K875367 · Decision Mar 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    88

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    Basic Information

    Device Name
    COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV
    K Number
    K875367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Enzo Biochem, Inc.
    Date Received
    December 31, 1987
    Decision Date
    March 28, 1988
    Product Code
    GQM
    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
    GQM Antisera, Neutralization, Herpesvirus Hominis

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