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

    ACCRAASSAY RID KITS

    K Number: K882369 · Decision Jul 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    75
    Applicant Total
    2
    Review Days
    34

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    Basic Information

    Device Name
    ACCRAASSAY RID KITS
    K Number
    K882369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Icn Immunobiologicals
    Date Received
    June 8, 1988
    Decision Date
    July 12, 1988
    Product Code
    DEW
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DEW Igg, Antigen, Antiserum, Control

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    Other Clearances by Icn Immunobiologicals

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