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

    INSULIN RADIOIMMUNOASSAY KIT

    K Number: K841573 · Decision May 16, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    26
    Applicant Total
    20
    Review Days
    29

    Basic Information

    Device Name
    INSULIN RADIOIMMUNOASSAY KIT
    K Number
    K841573
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1405
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    SORIN BIOMEDICA, FIAT, USA, INC.
    Date Received
    April 17, 1984
    Decision Date
    May 16, 1984
    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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