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

    AMPLIVUE C. DIFFICILE ASSAY

    K Number: K123355 · Decision Dec 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    16
    Applicant Total
    37
    Review Days
    43

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    Basic Information

    Device Name
    AMPLIVUE C. DIFFICILE ASSAY
    K Number
    K123355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3130
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quidel Corporation
    Date Received
    October 31, 2012
    Decision Date
    December 13, 2012
    Product Code
    OZN
    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
    OZN C. Difficile Toxin Gene Amplification Assay

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