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

    CEDIA CORTISOL ASSAY

    K Number: K893954 · Decision Oct 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    19
    Applicant Total
    107
    Review Days
    152

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    Basic Information

    Device Name
    CEDIA CORTISOL ASSAY
    K Number
    K893954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Microgenics Corp.
    Date Received
    June 1, 1989
    Decision Date
    October 31, 1989
    Product Code
    JFT
    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
    JFT Fluorometric, Cortisol

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