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

    SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT

    K Number: K113433 · Decision Apr 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    14
    Review Days
    135

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    Basic Information

    Device Name
    SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
    K Number
    K113433
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Focus Diagnostics, Inc.
    Date Received
    November 21, 2011
    Decision Date
    April 4, 2012
    Product Code
    OMN
    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
    OMN C. Difficile Nucleic Acid Amplification Test Assay

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