BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OSOM INFLUENZA A&B TEST MODEL 190

    K Number: K123182 · Decision Nov 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    6
    Review Days
    26

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    Basic Information

    Device Name
    OSOM INFLUENZA A&B TEST MODEL 190
    K Number
    K123182
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SEKISUI Diagnostics, LLC
    Date Received
    October 10, 2012
    Decision Date
    November 5, 2012
    Product Code
    GNX
    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
    GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

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