{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Newark",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "P.O. Box 6101 Bldg. 500;M.S.514",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "CEC",
      "openfda": {
        "registration_number": [
          "3006198300",
          "3033967997",
          "2432235",
          "3005529799",
          "3009092698",
          "3004192065",
          "3007111389",
          "2517506",
          "9680746",
          "2032839",
          "3014279513",
          "9612316",
          "3010825766",
          "2122870",
          "8031673",
          "1827821",
          "2245285",
          "3022178699",
          "2029372",
          "3007349751",
          "9610240",
          "3002809144",
          "3012963943",
          "2032087",
          "3002642396",
          "2250051",
          "3004434309",
          "3005333358",
          "3000308930",
          "1319681",
          "9610126",
          "3005094123",
          "3010324880",
          "1036362",
          "2419955",
          "3002806944",
          "3009518015",
          "3002800697",
          "2020726",
          "1219913",
          "3011989923",
          "1063851",
          "8020888"
        ],
        "fei_number": [
          "3006198300",
          "3033967997",
          "2432235",
          "3005529799",
          "3009092698",
          "3004192065",
          "3007111389",
          "2517506",
          "3014279513",
          "3010825766",
          "2122870",
          "1827821",
          "2967",
          "3002808212",
          "2245285",
          "3022178699",
          "3007349751",
          "3002809144",
          "3012963943",
          "1000442352",
          "1000306617",
          "3002642396",
          "2250051",
          "3004434309",
          "3005333358",
          "3000308930",
          "3005094123",
          "3010324880",
          "3003355251",
          "1036362",
          "2419955",
          "3002806944",
          "3009518015",
          "3002806559",
          "3002800697",
          "2020726",
          "1219913",
          "3002808328",
          "3011989923",
          "3004185580",
          "3007019572",
          "1000206808",
          "1000136573"
        ],
        "device_name": "Radioimmunoassay, Free Thyroxine",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1695",
        "device_class": "2"
      },
      "zip_code": "19714",
      "applicant": "Dade Behring, Inc.",
      "decision_date": "2006-03-03",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR",
      "advisory_committee": "CH",
      "contact": "LORRAINE H PIESTRAK",
      "expedited_review_flag": "",
      "k_number": "K053531",
      "state": "DE",
      "date_received": "2005-12-19",
      "review_advisory_committee": "CH",
      "postal_code": "19714",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}