BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    RANDOX AMIKACIN

    K Number: K033884 · Decision Jun 9, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    19
    Applicant Total
    116
    Review Days
    177

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    Basic Information

    Device Name
    RANDOX AMIKACIN
    K Number
    K033884
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3035
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Randox Laboratories, Ltd.
    Date Received
    December 15, 2003
    Decision Date
    June 9, 2004
    Product Code
    KLQ
    Advisory Committee
    Clinical Toxicology
    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
    KLQ Radioimmunoassay, Amikacin

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