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

    RIA KIT, PROGESTERONE

    K Number: K782009 · Decision Mar 2, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    56
    Applicant Total
    6
    Review Days
    91

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    Basic Information

    Device Name
    RIA KIT, PROGESTERONE
    K Number
    K782009
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1620
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    The Upjohn Co.
    Date Received
    December 1, 1978
    Decision Date
    March 2, 1979
    Product Code
    JLS
    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
    JLS Radioimmunoassay, Progesterone

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