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

    FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES

    K Number: K863798 · Decision Apr 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    30
    Review Days
    197

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    Basic Information

    Device Name
    FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES
    K Number
    K863798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Whittaker Bioproducts, Inc.
    Date Received
    September 29, 1986
    Decision Date
    April 14, 1987
    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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