BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    X100 with Full Field Peripheral Blood Smear (PBS) Application

    K Number: K201301 · Decision Oct 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    34
    Applicant Total
    4
    Review Days
    140

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    Basic Information

    Device Name
    X100 with Full Field Peripheral Blood Smear (PBS) Application
    K Number
    K201301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5260
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scopio Labs , Ltd.
    Date Received
    May 15, 2020
    Decision Date
    October 2, 2020
    Product Code
    JOY
    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
    JOY Device, Automated Cell-Locating

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    Other Clearances by Scopio Labs , Ltd.

    K Number Device Name
    K243144 X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
    DEN230034 X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
    K220013 X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application