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

    IMMUNOREACTIVE ESTRIOL RIA KIT

    K Number: K802754 · Decision Jan 21, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    41
    Applicant Total
    8
    Review Days
    79

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    Basic Information

    Device Name
    IMMUNOREACTIVE ESTRIOL RIA KIT
    K Number
    K802754
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1265
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Microanalytic Research, Inc.
    Date Received
    November 3, 1980
    Decision Date
    January 21, 1981
    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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