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

    MICROHEMATOCRIT CENTRIFUGE

    K Number: K864039 · Decision Oct 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    13

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    Basic Information

    Device Name
    MICROHEMATOCRIT CENTRIFUGE
    K Number
    K864039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5600
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Plaza Medical, Inc.
    Date Received
    October 16, 1986
    Decision Date
    October 29, 1986
    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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