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

    MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE

    K Number: K915441 · Decision Jan 8, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    14
    Applicant Total
    89
    Review Days
    35

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    Basic Information

    Device Name
    MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE
    K Number
    K915441
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5600
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fisher Scientific Co., LLC
    Date Received
    December 4, 1991
    Decision Date
    January 8, 1992
    Product Code
    GKF
    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
    GKF Instrument, Hematocrit, Automated

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