BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ACTHK-PR RIA KIT

    K Number: K860311 · Decision Apr 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    69

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    Basic Information

    Device Name
    ACTHK-PR RIA KIT
    K Number
    K860311
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1025
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Compagnie Oris Industrie, S.A.
    Date Received
    January 28, 1986
    Decision Date
    April 7, 1986
    Product Code
    CKG
    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
    CKG Radioimmunoassay, Acth

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    Other Clearances by Compagnie Oris Industrie, S.A.

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