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

    TOTAL HAEMOLYTIC COMPLEMENT RID KIT

    K Number: K992488 · Decision Sep 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    5
    Applicant Total
    115
    Review Days
    53

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    Basic Information

    Device Name
    TOTAL HAEMOLYTIC COMPLEMENT RID KIT
    K Number
    K992488
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site, Ltd.
    Date Received
    July 26, 1999
    Decision Date
    September 17, 1999
    Product Code
    DAE
    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
    DAE Complement C9, Antigen, Antiserum, Control

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