BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇩🇪 Germany

    B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System

    K Number: DEN220027 · Decision May 18, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    381

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    Basic Information

    Device Name
    B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
    K Number
    DEN220027
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    862.1602
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Applicant
    Brahms GmbH, Part of Thermo Fisher Scientific
    Date Received
    May 2, 2022
    Decision Date
    May 18, 2023
    Product Code
    QWH
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QWH Prognostic Test For Development Or Progression Of Preeclampsia

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