BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇦 Canada

    NP Screen

    K Number: DEN190031 · Decision May 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    322

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    Basic Information

    Device Name
    NP Screen
    K Number
    DEN190031
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3236
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Advance Sentry Corporation
    Date Received
    June 24, 2019
    Decision Date
    May 11, 2020
    Product Code
    OJY
    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
    OJY Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers