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

    CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY

    K Number: K813033 · Decision Apr 9, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    10
    Applicant Total
    632
    Review Days
    163

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    Basic Information

    Device Name
    CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY
    K Number
    K813033
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    October 28, 1981
    Decision Date
    April 9, 1982
    Product Code
    GKG
    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
    GKG Centrifuge, Hematocrit

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