BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101

    K Number: K874623 · Decision Feb 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    17
    Review Days
    98

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    Basic Information

    Device Name
    FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101
    K Number
    K874623
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Cyberfluor, Inc.
    Date Received
    November 10, 1987
    Decision Date
    February 16, 1988
    Product Code
    CDX
    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
    CDX Radioimmunoassay, Total Thyroxine

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