{
  "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": "East Walpole",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "333 Coney St.",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "CEP",
      "openfda": {
        "registration_number": [
          "2032682",
          "3009335633",
          "3011989923",
          "3003233791",
          "3033482477",
          "3033967997",
          "3013679502",
          "3017019647",
          "1036362",
          "8020888",
          "3009491259",
          "2517506",
          "3017379203",
          "3007111389",
          "1319436",
          "3004569406",
          "9610240",
          "3005984081",
          "2060833",
          "2031229",
          "2432235",
          "8031673",
          "3015341499",
          "8043510",
          "1319681",
          "3003741796",
          "3014848805",
          "2020726",
          "3013284090",
          "3002800697",
          "8010132",
          "3005641941",
          "1649661",
          "3005094123",
          "3022178699",
          "3003917514",
          "8043909",
          "2031824",
          "3009984016",
          "1827821",
          "3014171027",
          "2246703",
          "2122870",
          "3005128563",
          "3007583565",
          "3008198807",
          "3010220539",
          "9610126",
          "3006635320",
          "1219913",
          "3003829675",
          "3004434309",
          "3001034529",
          "2032839",
          "2245285",
          "3005529799",
          "9612316",
          "3016837106",
          "1832216",
          "3024463179",
          "3005951403",
          "2280705",
          "3005360469",
          "3006198300",
          "3013160357",
          "3002809144",
          "3005333358",
          "2029372",
          "8020790",
          "9680746",
          "3002806944",
          "2025099",
          "1222302"
        ],
        "fei_number": [
          "3003952975",
          "3009335633",
          "3011989923",
          "3003233791",
          "3002757762",
          "3002808212",
          "3013679502",
          "3002806559",
          "1036362",
          "3017019647",
          "3009491259",
          "3033482477",
          "2517506",
          "3017379203",
          "3007111389",
          "3004569406",
          "3005984081",
          "2432235",
          "3015341499",
          "1000121039",
          "3003741796",
          "3014848805",
          "3001451797",
          "3007019572",
          "2020726",
          "3013284090",
          "3002800697",
          "3002808498",
          "3005641941",
          "3005094123",
          "3022178699",
          "1000136573",
          "3003917514",
          "3004185580",
          "3009984016",
          "1000306617",
          "1827821",
          "3014171027",
          "3001452245",
          "2246703",
          "3005670738",
          "2122870",
          "3005128563",
          "3007583565",
          "1000206808",
          "3008198807",
          "3010220539",
          "3006635320",
          "1219913",
          "3003829675",
          "3004434309",
          "3001034529",
          "3007981058",
          "2245285",
          "3005529799",
          "1000120319",
          "3033967997",
          "2967",
          "3016837106",
          "1832216",
          "3002808328",
          "3024463179",
          "3005951403",
          "2280705",
          "3006198300",
          "3013160357",
          "3002806808",
          "3002809144",
          "3005333358",
          "1000611339",
          "3000719950",
          "3002806944",
          "3003335291"
        ],
        "device_name": "Radioimmunoassay, Luteinizing Hormone",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1485",
        "device_class": "1"
      },
      "zip_code": "02032",
      "applicant": "Ciba Corning Diagnostics Corp.",
      "decision_date": "1990-06-28",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "CIBA CORNING MAGIC LITE LH IMMUNOASSAY",
      "advisory_committee": "CH",
      "contact": "William J Pignato",
      "expedited_review_flag": "",
      "k_number": "K902398",
      "state": "MA",
      "date_received": "1990-05-30",
      "review_advisory_committee": "CH",
      "postal_code": "02032",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}