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

    UNIVERSAL CENTRIFUGE

    K Number: K822716 · Decision Sep 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    14
    Applicant Total
    21
    Review Days
    23

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    Basic Information

    Device Name
    UNIVERSAL CENTRIFUGE
    K Number
    K822716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Biodynamics Corp.
    Date Received
    September 7, 1982
    Decision Date
    September 30, 1982
    Product Code
    JPI
    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
    JPI Device, Hematocrit Measuring

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