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

    CYTOMEGALO VIRUS & CONTROLS

    K Number: K802930 · Decision Jan 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    18
    Applicant Total
    28
    Review Days
    51

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    Basic Information

    Device Name
    CYTOMEGALO VIRUS & CONTROLS
    K Number
    K802930
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Orion Diagnostica, Inc.
    Date Received
    November 19, 1980
    Decision Date
    January 9, 1981
    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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