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

    HEMAGEN CMV IGG KIT

    K Number: K944438 · Decision Feb 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    57
    Applicant Total
    52
    Review Days
    892

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    Basic Information

    Device Name
    HEMAGEN CMV IGG KIT
    K Number
    K944438
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemagen Diagnostics, Inc.
    Date Received
    September 12, 1994
    Decision Date
    February 20, 1997
    Product Code
    LFZ
    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
    LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

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