{
  "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": "Northbrook",
      "advisory_committee_description": "Clinical Toxicology",
      "address_1": "4088 Commercial Ave.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NTI",
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          "3021047648",
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        "device_name": "Drug Metabolizing Enzyme Genotyping Systems",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3360",
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      "applicant": "Nanosphere, Inc.",
      "decision_date": "2012-11-06",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)",
      "advisory_committee": "TX",
      "contact": "MARK  DEL VECCHIO",
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      "k_number": "K120466",
      "state": "IL",
      "date_received": "2012-02-15",
      "review_advisory_committee": "TX",
      "postal_code": "60062",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}