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

    ROCHE AMPLICHIP CYP450 TEST

    K Number: K043576 · Decision Jan 10, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    51
    Review Days
    14

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    Basic Information

    Device Name
    ROCHE AMPLICHIP CYP450 TEST
    K Number
    K043576
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3360
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    December 27, 2004
    Decision Date
    January 10, 2005
    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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