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

    CORTISOL RIA KIT

    K Number: K790268 · Decision Apr 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    83
    Applicant Total
    32
    Review Days
    58

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    Basic Information

    Device Name
    CORTISOL RIA KIT
    K Number
    K790268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E. R. Squibb & Sons, Inc.
    Date Received
    February 5, 1979
    Decision Date
    April 4, 1979
    Product Code
    CGR
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    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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