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

    RADIOIMMUNOASSAY PARATHYROID HORMONE MID

    K Number: K821131 · Decision Jun 2, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    85
    Applicant Total
    9
    Review Days
    43

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    Basic Information

    Device Name
    RADIOIMMUNOASSAY PARATHYROID HORMONE MID
    K Number
    K821131
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1545
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Endocrine-Metabolic Center
    Date Received
    April 20, 1982
    Decision Date
    June 2, 1982
    Product Code
    CEW
    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
    CEW Radioimmunoassay, Parathyroid Hormone

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    Other Clearances by Endocrine-Metabolic Center

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    K810948 RADIOIMMUNOASSAY THYROID STIM. HORM. KIT
    K810351 RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE
    K800188 EMC-M-180, T3 UPTAKE - 100 TUBES
    K800187 EMC-M-175, THYROXINE - 100 TUBES
    K790602 RIA, DIGNXIN-125-I
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