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

    HTSH RIA HUMAN THYROID HORMONE RIA

    K Number: K771235 · Decision Aug 3, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    240
    Applicant Total
    857
    Review Days
    23

    Basic Information

    Device Name
    HTSH RIA HUMAN THYROID HORMONE RIA
    K Number
    K771235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    ABBOTT LABORATORIES
    Date Received
    July 11, 1977
    Decision Date
    August 3, 1977
    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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