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

    RADIOIMMUNOASSAY, THYROID STIMU. HORMONE

    K Number: K833193 · Decision Feb 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    10
    Review Days
    138

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    Basic Information

    Device Name
    RADIOIMMUNOASSAY, THYROID STIMU. HORMONE
    K Number
    K833193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biosan Laboratories, Inc.
    Date Received
    September 19, 1983
    Decision Date
    February 4, 1984
    Product Code
    JLW
    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
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

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