BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇦🇹 Austria

    Technozym ADAMTS13 Activity

    K Number: DEN230024 · Decision Feb 28, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    328

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    Basic Information

    Device Name
    Technozym ADAMTS13 Activity
    K Number
    DEN230024
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    864.7297
    Medical Specialty
    Hematology
    Decision
    Unknown
    Applicant
    Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM
    Date Received
    April 6, 2023
    Decision Date
    February 28, 2024
    Product Code
    SAC
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SAC Adamts13 Activity Test System