{
  "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": "2026-06-01",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Madison",
      "advisory_committee_description": "Clinical Toxicology",
      "address_1": "502 S. Rosa Rd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NTI",
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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": "Third Wave Technologies, Inc.",
      "decision_date": "2005-08-18",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "INVADER UGT1A1 MOLECULAR ASSAY",
      "advisory_committee": "TX",
      "contact": "Sam  Rua",
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      "k_number": "K051824",
      "state": "WI",
      "date_received": "2005-07-05",
      "review_advisory_committee": "CH",
      "postal_code": "53719",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}