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

    RANDOX BENZODIAZEPINE CLASS ASSAY

    K Number: K050179 · Decision May 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    89
    Applicant Total
    116
    Review Days
    111

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    Basic Information

    Device Name
    RANDOX BENZODIAZEPINE CLASS ASSAY
    K Number
    K050179
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3170
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Randox Laboratories, Ltd.
    Date Received
    January 26, 2005
    Decision Date
    May 17, 2005
    Product Code
    JXM
    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
    JXM Enzyme Immunoassay, Benzodiazepine

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