{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Toronto, On",
      "advisory_committee_description": "Immunology",
      "address_1": "36 Meteor Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "DHR",
      "openfda": {
        "registration_number": [
          "1181055",
          "2032682",
          "3011989923",
          "2084025",
          "9610529",
          "3003795116",
          "2250030",
          "3004493545",
          "1318354",
          "2016706",
          "9610746",
          "3021841051",
          "3015376545",
          "2026994",
          "3012963943",
          "2432235",
          "1616487",
          "3016438761",
          "3003871639",
          "2050010",
          "1319681",
          "1319808",
          "2250051",
          "2020726",
          "3002800697",
          "9610806",
          "1421346",
          "8043792",
          "3002642396",
          "1649661",
          "3005094123",
          "3022178699",
          "1000403749",
          "1641328",
          "3004973408",
          "3000308930",
          "1827821",
          "2029372",
          "9610126",
          "2050012",
          "3010127294",
          "3007208259",
          "3000148879",
          "1181121",
          "2245285",
          "1832216",
          "3017505309",
          "9614373",
          "3005360469",
          "3006198300",
          "3012471076",
          "3012348571",
          "3002809144",
          "3005333358",
          "9610566",
          "9680746",
          "2242436"
        ],
        "fei_number": [
          "1181055",
          "3003952975",
          "3011989923",
          "2084025",
          "3003795116",
          "3002806559",
          "2250030",
          "3004493545",
          "3001644026",
          "3002808340",
          "1318354",
          "2016706",
          "3021841051",
          "3015376545",
          "2026994",
          "3012963943",
          "1000305841",
          "2432235",
          "3016438761",
          "1616487",
          "3003871639",
          "2050010",
          "3002806560",
          "3001451797",
          "2250051",
          "2020726",
          "3002800697",
          "1421346",
          "3002642396",
          "3005094123",
          "3022178699",
          "1000403749",
          "1641328",
          "3004973408",
          "1000136573",
          "3000308930",
          "1000306617",
          "1827821",
          "3002807876",
          "3005670738",
          "1000206808",
          "2050012",
          "3010127294",
          "3007208259",
          "3000148879",
          "3002808269",
          "1181121",
          "2245285",
          "1832216",
          "3017505309",
          "3006198300",
          "3012471076",
          "3012348571",
          "3002809144",
          "3005333358",
          "2242436",
          "3002806557"
        ],
        "device_name": "System, Test, Rheumatoid Factor",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5775",
        "device_class": "2"
      },
      "zip_code": "M9W 1A4",
      "applicant": "Sqi Diagnostics Systems",
      "decision_date": "2009-10-29",
      "decision_code": "SESE",
      "country_code": "CA",
      "device_name": "IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM",
      "advisory_committee": "IM",
      "contact": "Kate  Smith",
      "expedited_review_flag": "",
      "k_number": "K083080",
      "state": "",
      "date_received": "2008-10-16",
      "review_advisory_committee": "IM",
      "postal_code": "M9W 1A4",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}