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

    CYTOMEGALOVIRUS CONTROL SLIDES

    K Number: K873114 · Decision Sep 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    18
    Applicant Total
    57
    Review Days
    46

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    Basic Information

    Device Name
    CYTOMEGALOVIRUS CONTROL SLIDES
    K Number
    K873114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Medical Diagnostic Technologies, Inc.
    Date Received
    August 10, 1987
    Decision Date
    September 25, 1987
    Product Code
    GQH
    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
    GQH Antigen, Cf (Including Cf Control), Cytomegalovirus

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