BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NSULIN RIA KIT 125I

    K Number: K771628 · Decision Sep 20, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    26
    Applicant Total
    632
    Review Days
    25

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    Basic Information

    Device Name
    NSULIN RIA KIT 125I
    K Number
    K771628
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1405
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    August 26, 1977
    Decision Date
    September 20, 1977
    Product Code
    CFP
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CFP Radioimmunoassay, Immunoreactive Insulin

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