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

    COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE

    K Number: K070062 · Decision Jul 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    62
    Applicant Total
    2
    Review Days
    206

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    Basic Information

    Device Name
    COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
    K Number
    K070062
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diesse Diagnostica Senese S.P.A.
    Date Received
    January 5, 2007
    Decision Date
    July 30, 2007
    Product Code
    LIO
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LIO Device, Specimen Collection

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    Other Clearances by Diesse Diagnostica Senese S.P.A.

    K Number Device Name
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