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

    ACCURUN 146 CMV IGM POSITIVE CONTROL

    K Number: K972884 · Decision Aug 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    12
    Review Days
    17

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    Basic Information

    Device Name
    ACCURUN 146 CMV IGM POSITIVE CONTROL
    K Number
    K972884
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Biomedica, Inc.
    Date Received
    August 5, 1997
    Decision Date
    August 22, 1997
    Product Code
    LKQ
    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
    LKQ Antibody Igm,If, Cytomegalovirus Virus

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