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

    PORTRAIT ANALYZER

    K Number: DEN120013 · Decision Apr 30, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    59

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    Basic Information

    Device Name
    PORTRAIT ANALYZER
    K Number
    DEN120013
    Device Class
    FDA class 1
    Clearance Type
    Post-NSE
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Great Basin Scientific
    Date Received
    March 2, 2012
    Decision Date
    April 30, 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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