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

    MODIFIED DDI SEROCARD CMV IGG TEST KIT

    K Number: K884248 · Decision Apr 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    57
    Applicant Total
    20
    Review Days
    181

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    Basic Information

    Device Name
    MODIFIED DDI SEROCARD CMV IGG TEST KIT
    K Number
    K884248
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Disease Detection International, Inc.
    Date Received
    October 11, 1988
    Decision Date
    April 10, 1989
    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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