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

    SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST

    K Number: K061496 · Decision Jun 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    393

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    Basic Information

    Device Name
    SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
    K Number
    K061496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sa Scientific , Ltd.
    Date Received
    May 31, 2006
    Decision Date
    June 28, 2007
    Product Code
    MJH
    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
    MJH Legionella, Spp., Elisa

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    Other Clearances by Sa Scientific , Ltd.

    K Number Device Name
    K132352 SAS FLUALERT A & B, SAS INFLUENZA A TEST