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

    NORDICLAB TOTAL ESTRIOL RIA TEST

    K Number: K792189 · Decision Nov 13, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    41
    Applicant Total
    8
    Review Days
    13

    Basic Information

    Device Name
    NORDICLAB TOTAL ESTRIOL RIA TEST
    K Number
    K792189
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1265
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    NORDICLAB INTL.
    Date Received
    October 31, 1979
    Decision Date
    November 13, 1979
    Product Code
    CGI
    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
    CGI Radioimmunoassay, Estriol

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