BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    RANDOX TRANSFERRIN

    K Number: K002585 · Decision Feb 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    116
    Review Days
    168

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    Basic Information

    Device Name
    RANDOX TRANSFERRIN
    K Number
    K002585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5880
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Randox Laboratories, Ltd.
    Date Received
    August 21, 2000
    Decision Date
    February 5, 2001
    Product Code
    DDG
    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
    DDG Transferrin, Antigen, Antiserum, Control

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