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

    PHASE II CORTISOL KIT

    K Number: K834219 · Decision Feb 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    83
    Applicant Total
    14
    Review Days
    61

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    Basic Information

    Device Name
    PHASE II CORTISOL KIT
    K Number
    K834219
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medical & Scientific Designs, Inc.
    Date Received
    December 5, 1983
    Decision Date
    February 4, 1984
    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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