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

    CORTISOL 125-I RADIOIMMUNOASSAY KIT

    K Number: K802969 · Decision Jan 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    83
    Applicant Total
    9
    Review Days
    42

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    Basic Information

    Device Name
    CORTISOL 125-I RADIOIMMUNOASSAY KIT
    K Number
    K802969
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Ria Products, Inc.
    Date Received
    November 21, 1980
    Decision Date
    January 2, 1981
    Product Code
    CGR
    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
    CGR Radioimmunoassay, Cortisol

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