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

    ACTH IRMA KIT II MITSUBISHI YUKA

    K Number: K915727 · Decision Mar 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    73

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    Basic Information

    Device Name
    ACTH IRMA KIT II MITSUBISHI YUKA
    K Number
    K915727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1025
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mitsubishi Yuka America, Inc.
    Date Received
    December 20, 1991
    Decision Date
    March 2, 1992
    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 Mitsubishi Yuka America, Inc.

    K Number Device Name
    K912536 CALCITONIN KIT MITSUBISHI YUKA