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

    AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL

    K Number: K020618 · Decision May 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    6
    Applicant Total
    35
    Review Days
    78

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    Basic Information

    Device Name
    AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
    K Number
    K020618
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aalto Scientific, Ltd.
    Date Received
    February 25, 2002
    Decision Date
    May 14, 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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