{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-13",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Pleasanton",
      "advisory_committee_description": "Clinical Toxicology",
      "address_1": "4300 Hacienda Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NTI",
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          "3021047648",
          "3005406097"
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        "device_name": "Drug Metabolizing Enzyme Genotyping Systems",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3360",
        "device_class": "2"
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      "applicant": "Roche Molecular Systems, Inc.",
      "decision_date": "2005-01-10",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ROCHE AMPLICHIP CYP450 TEST",
      "advisory_committee": "TX",
      "contact": "JAMES F KELLY",
      "expedited_review_flag": "",
      "k_number": "K043576",
      "state": "CA",
      "date_received": "2004-12-27",
      "review_advisory_committee": "CH",
      "postal_code": "94588",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}