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

    CIRCULATING IMMUNE COMPLEXES CONTROLS

    K Number: K882829 · Decision Aug 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    27
    Applicant Total
    10
    Review Days
    27

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    Basic Information

    Device Name
    CIRCULATING IMMUNE COMPLEXES CONTROLS
    K Number
    K882829
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Cytotech, Inc.
    Date Received
    July 8, 1988
    Decision Date
    August 4, 1988
    Product Code
    DAK
    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
    DAK Complement C1q, Antigen, Antiserum, Control

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