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

    RANDOX BARITURATES ASSAY

    K Number: K092268 · Decision May 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    116
    Review Days
    666

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    Basic Information

    Device Name
    RANDOX BARITURATES ASSAY
    K Number
    K092268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Randox Laboratories, Ltd.
    Date Received
    July 28, 2009
    Decision Date
    May 25, 2011
    Product Code
    DIS
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DIS Enzyme Immunoassay, Barbiturate

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