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

    RH CONTROL DILUENT

    K Number: K770185 · Decision Mar 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    3
    Applicant Total
    632
    Review Days
    46

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    Basic Information

    Device Name
    RH CONTROL DILUENT
    K Number
    K770185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9175
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    January 27, 1977
    Decision Date
    March 14, 1977
    Product Code
    KSZ
    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
    KSZ System, Test, Automated Blood Grouping And Antibody

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