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

    CETUS CMV IHA

    K Number: K822965 · Decision Feb 15, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    3
    Review Days
    131

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    Basic Information

    Device Name
    CETUS CMV IHA
    K Number
    K822965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Cetus Corp.
    Date Received
    October 7, 1982
    Decision Date
    February 15, 1983
    Product Code
    LJO
    Advisory Committee
    Microbiology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJO Antigen, Iha, Cytomegalovirus

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