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

    TSH-SQUIBB RADIOIMMUNOASSAY KIT

    K Number: K821174 · Decision May 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    5
    Review Days
    18

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    Basic Information

    Device Name
    TSH-SQUIBB RADIOIMMUNOASSAY KIT
    K Number
    K821174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Squibb & Sons, Inc.
    Date Received
    April 26, 1982
    Decision Date
    May 14, 1982
    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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