BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇱 Israel

    X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application

    K Number: DEN230034 · Decision Mar 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    329

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    Basic Information

    Device Name
    X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
    K Number
    DEN230034
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    864.5261
    Medical Specialty
    Hematology
    Decision
    Unknown
    Applicant
    Scopio Labs , Ltd.
    Date Received
    April 28, 2023
    Decision Date
    March 22, 2024
    Product Code
    SAL
    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
    SAL Device, Automated Cell Locating, Bone Marrow

    Other Clearances by Scopio Labs , Ltd.

    K Number Device Name
    K243144 X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
    K220013 X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
    K201301 X100 with Full Field Peripheral Blood Smear (PBS) Application