{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Indianapolis",
      "advisory_committee_description": "Clinical Toxicology",
      "address_1": "9115 Hague Rd., P.O. Box 50457",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "LBZ",
      "openfda": {
        "registration_number": [
          "3003795116",
          "3006198300",
          "3010939897",
          "9610529",
          "3005333358",
          "2517506",
          "9610126"
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          "3006198300",
          "3010939897",
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          "2517506",
          "3002806560"
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        "device_name": "Enzyme Immunoassay, Quinidine",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3320",
        "device_class": "2"
      },
      "zip_code": "46250",
      "applicant": "Roche Diagnostics Corp.",
      "decision_date": "2004-01-12",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ROCHE ONLINE TDM QUINIDINE",
      "advisory_committee": "TX",
      "contact": "MIKE  FLIS",
      "expedited_review_flag": "",
      "k_number": "K032332",
      "state": "IN",
      "date_received": "2003-07-29",
      "review_advisory_committee": "TX",
      "postal_code": "46250",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}