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

    RANDOX DIGITOXIN

    K Number: K012112 · Decision Jan 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    19
    Applicant Total
    116
    Review Days
    189

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    Basic Information

    Device Name
    RANDOX DIGITOXIN
    K Number
    K012112
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3300
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Randox Laboratories, Ltd.
    Date Received
    July 6, 2001
    Decision Date
    January 11, 2002
    Product Code
    LFM
    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
    LFM Enzyme Immunoassay, Digitoxin

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