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

    ELEGANCE PROLACTIN ELISA

    K Number: K904483 · Decision Nov 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    79
    Applicant Total
    10
    Review Days
    34

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    Basic Information

    Device Name
    ELEGANCE PROLACTIN ELISA
    K Number
    K904483
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1625
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bioclone Australia Pty , Ltd.
    Date Received
    October 2, 1990
    Decision Date
    November 5, 1990
    Product Code
    CFT
    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
    CFT Radioimmunoassay, Prolactin (Lactogen)

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