BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    AMPLICHIP CYP450 TEST, MODEL 04381866190

    K Number: DEN040011 · Decision Dec 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    51
    Review Days
    3

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    Basic Information

    Device Name
    AMPLICHIP CYP450 TEST, MODEL 04381866190
    K Number
    DEN040011
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    862.3360
    Medical Specialty
    Clinical Toxicology
    Decision
    Unknown
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    December 20, 2004
    Decision Date
    December 23, 2004
    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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