BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT

    K Number: K841947 · Decision Jun 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    49
    Applicant Total
    20
    Review Days
    42

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    Basic Information

    Device Name
    ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT
    K Number
    K841947
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sorin Biomedica, Fiat, USA, Inc.
    Date Received
    May 14, 1984
    Decision Date
    June 25, 1984
    Product Code
    CHP
    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
    CHP Radioimmunoassay, Estradiol

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