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

    xTAG CYP2D6 Kit v3

    K Number: K170492 · Decision Aug 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    10
    Review Days
    175

    Basic Information

    Device Name
    xTAG CYP2D6 Kit v3
    K Number
    K170492
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3360
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Luminex Molecular Diagnostics, Inc.
    Date Received
    February 17, 2017
    Decision Date
    August 11, 2017
    Product Code
    NTI
    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
    NTI Drug Metabolizing Enzyme Genotyping Systems

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