BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)

    K Number: K130189 · Decision May 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    26
    Review Days
    116

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    Basic Information

    Device Name
    XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
    K Number
    K130189
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3360
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Luminex Molecular Diagnostics, Inc.
    Date Received
    January 25, 2013
    Decision Date
    May 21, 2013
    Product Code
    NTI
    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
    NTI Drug Metabolizing Enzyme Genotyping Systems

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    Other Clearances by Luminex Molecular Diagnostics, Inc.

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    K170492 xTAG CYP2D6 Kit v3
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