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

    ACTH RIA SYSTEM-DSI 2300

    K Number: K830893 · Decision Apr 27, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    29
    Applicant Total
    94
    Review Days
    37

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    Basic Information

    Device Name
    ACTH RIA SYSTEM-DSI 2300
    K Number
    K830893
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1025
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Systems Laboratories, Inc.
    Date Received
    March 21, 1983
    Decision Date
    April 27, 1983
    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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