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

    ADX TM OPIATES

    K Number: K890689 · Decision Aug 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    883
    Review Days
    192

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    Basic Information

    Device Name
    ADX TM OPIATES
    K Number
    K890689
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5230
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Abbott Laboratories
    Date Received
    February 14, 1989
    Decision Date
    August 25, 1989
    Product Code
    DGJ
    Advisory Committee
    Immunology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DGJ Colostrum, Antigen, Antiserum, Control

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