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

    RANDOX DIGOXIN ASSAY

    K Number: K102346 · Decision Oct 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    84
    Applicant Total
    116
    Review Days
    421

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    Basic Information

    Device Name
    RANDOX DIGOXIN ASSAY
    K Number
    K102346
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Randox Laboratories, Ltd.
    Date Received
    August 19, 2010
    Decision Date
    October 14, 2011
    Product Code
    KXT
    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
    KXT Enzyme Immunoassay, Digoxin

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