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

    Great Basin Toxigenic C. difficile Direct Test (CDF2)

    K Number: K232092 · Decision Nov 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    124

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    Basic Information

    Device Name
    Great Basin Toxigenic C. difficile Direct Test (CDF2)
    K Number
    K232092
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3130
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vela Operations USA
    Date Received
    July 13, 2023
    Decision Date
    November 14, 2023
    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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