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

    CENTRIA CORTISOL RIA

    K Number: K771117 · Decision Jun 23, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    83
    Applicant Total
    8
    Review Days
    2

    Basic Information

    Device Name
    CENTRIA CORTISOL RIA
    K Number
    K771117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    CLINICAL DIAGNOSTICS, INC.
    Date Received
    June 21, 1977
    Decision Date
    June 23, 1977
    Product Code
    CGR
    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
    CGR Radioimmunoassay, Cortisol

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