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

    CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY

    K Number: K935809 · Decision May 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    18
    Applicant Total
    19
    Review Days
    154

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    Basic Information

    Device Name
    CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
    K Number
    K935809
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Light Diagnostics
    Date Received
    December 2, 1993
    Decision Date
    May 5, 1994
    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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