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

    EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)

    K Number: DEN220090 · Decision Nov 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    329

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    Basic Information

    Device Name
    EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)
    K Number
    DEN220090
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.6120
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    Stemcell Technologies Canada, Inc.
    Date Received
    December 12, 2022
    Decision Date
    November 6, 2023
    Product Code
    QYO
    Advisory Committee
    Immunology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QYO Hematopoietic Cell Enrichment Kit