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

    Procise ADL

    K Number: DEN220023 · Decision Sep 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    543

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    Basic Information

    Device Name
    Procise ADL
    K Number
    DEN220023
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    862.3115
    Medical Specialty
    Clinical Toxicology
    Decision
    Unknown
    Applicant
    Procisedx, Inc.
    Date Received
    April 4, 2022
    Decision Date
    September 29, 2023
    Product Code
    QYD
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QYD Adalimumab Assay

    Other Clearances by Procisedx, Inc.

    K Number Device Name
    DEN210056 Procise IFX