BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇬🇧 United Kingdom

    Parsortix PC1 Device

    K Number: DEN200062 · Decision May 24, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    603

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    Basic Information

    Device Name
    Parsortix PC1 Device
    K Number
    DEN200062
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.6110
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    Angle Europe , Ltd.
    Date Received
    September 28, 2020
    Decision Date
    May 24, 2022
    Product Code
    QSA
    Advisory Committee
    Immunology
    Review Advisory Committee
    MG
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QSA Circulating Tumor Cell (Ctc) Enrichment Device