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

    INSULIN RIA MODULE

    K Number: K771947 · Decision Jan 20, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    26
    Applicant Total
    3
    Review Days
    95

    Basic Information

    Device Name
    INSULIN RIA MODULE
    K Number
    K771947
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1405
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    INTER SCIENCE INSTITUTE
    Date Received
    October 17, 1977
    Decision Date
    January 20, 1978
    Product Code
    CFP
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    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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    Other Clearances by INTER SCIENCE INSTITUTE

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