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

    RADIOIMMUNOASSAY THYROID STIM. HORM. KIT

    K Number: K810948 · Decision Apr 17, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    9
    Review Days
    10

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    Basic Information

    Device Name
    RADIOIMMUNOASSAY THYROID STIM. HORM. KIT
    K Number
    K810948
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Endocrine-Metabolic Center
    Date Received
    April 7, 1981
    Decision Date
    April 17, 1981
    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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    Other Clearances by Endocrine-Metabolic Center

    K Number Device Name
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    K811994 RADIOIMMUNOASSAY LUTEINIZING HORMONE
    K810351 RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE
    K800188 EMC-M-180, T3 UPTAKE - 100 TUBES
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    K790602 RIA, DIGNXIN-125-I
    K790630 RIA, INSULIN, DOUBLE ANTIBODY