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

    C3C AND C4 RID KITS

    K Number: K902382 · Decision Sep 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    43
    Applicant Total
    115
    Review Days
    100

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    Basic Information

    Device Name
    C3C AND C4 RID KITS
    K Number
    K902382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    The Binding Site, Ltd.
    Date Received
    May 30, 1990
    Decision Date
    September 7, 1990
    Product Code
    CZW
    Advisory Committee
    Immunology
    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
    CZW Complement C3, Antigen, Antiserum, Control

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