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

    CIBA CORNING ACS CORTISOL IMMUNOASSAY

    K Number: K945367 · Decision May 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    83
    Applicant Total
    125
    Review Days
    221

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    Basic Information

    Device Name
    CIBA CORNING ACS CORTISOL IMMUNOASSAY
    K Number
    K945367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    September 26, 1994
    Decision Date
    May 5, 1995
    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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