{
  "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": "Rochester",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "100 Indigo Creek Dr.",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "KLI",
      "openfda": {
        "registration_number": [
          "1181055",
          "2032682",
          "9610529",
          "3003795116",
          "3010939897",
          "1036362",
          "2247288",
          "2517506",
          "3007111389",
          "3009518015",
          "3005984081",
          "3012963943",
          "2432235",
          "8031673",
          "2050010",
          "1319681",
          "3014325803",
          "9615037",
          "3050015",
          "2250051",
          "2020726",
          "3002800697",
          "3002642396",
          "3005094123",
          "3022178699",
          "8043909",
          "3009984016",
          "3000308930",
          "1827821",
          "2122870",
          "9610126",
          "1219913",
          "2050012",
          "3003030793",
          "3005529799",
          "2245285",
          "9612316",
          "1832216",
          "3010825766",
          "3006198300",
          "3002809144",
          "3005333358",
          "2029372",
          "3002806944",
          "1222302"
        ],
        "fei_number": [
          "1181055",
          "3003952975",
          "3003795116",
          "3010939897",
          "3002806559",
          "1036362",
          "2517506",
          "3007111389",
          "3009518015",
          "3005984081",
          "3012963943",
          "2432235",
          "2050010",
          "1000121039",
          "3002806560",
          "3014325803",
          "3050015",
          "2250051",
          "2020726",
          "3002800697",
          "1000122044",
          "3002808498",
          "3002642396",
          "3005094123",
          "3022178699",
          "1000136573",
          "3009984016",
          "3000308930",
          "1827821",
          "1000306617",
          "2122870",
          "1219913",
          "2050012",
          "3003030793",
          "3005529799",
          "2245285",
          "2967",
          "1832216",
          "3002808328",
          "3003261083",
          "3010825766",
          "3006198300",
          "3002809144",
          "3005333358",
          "3002806944"
        ],
        "device_name": "Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1700",
        "device_class": "2"
      },
      "zip_code": "14650",
      "applicant": "Johnson & Johnson Clinical Diagnostics, Inc.",
      "decision_date": "1996-12-18",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)",
      "advisory_committee": "CH",
      "contact": "ANN M QUINN",
      "expedited_review_flag": "",
      "k_number": "K964721",
      "state": "NY",
      "date_received": "1996-11-25",
      "review_advisory_committee": "CH",
      "postal_code": "14650",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}