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

    NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM

    K Number: K860138 · Decision Mar 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    164
    Review Days
    73

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    Basic Information

    Device Name
    NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
    K Number
    K860138
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5210
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    January 14, 1986
    Decision Date
    March 28, 1986
    Product Code
    DDB
    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
    DDB Ceruloplasmin, Antigen, Antiserum, Control

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