BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MEDICA EASYQC HEMATOCRIT CONTROL

    K Number: K021924 · Decision Jun 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    6
    Applicant Total
    49
    Review Days
    13

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    Basic Information

    Device Name
    MEDICA EASYQC HEMATOCRIT CONTROL
    K Number
    K021924
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionostics, Inc.
    Date Received
    June 11, 2002
    Decision Date
    June 24, 2002
    Product Code
    GLK
    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
    GLK Control, Hematocrit

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