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

    CMV EARLY ANTIGEN TEST

    K Number: K942171 · Decision Jun 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    17
    Applicant Total
    20
    Review Days
    56

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    Basic Information

    Device Name
    CMV EARLY ANTIGEN TEST
    K Number
    K942171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neogenex
    Date Received
    May 5, 1994
    Decision Date
    June 30, 1994
    Product Code
    GQI
    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
    GQI Antiserum, Cf, Cytomegalovirus

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