{
  "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": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "LTK",
      "openfda": {
        "k_number": [
          "K983715",
          "K142895",
          "K983391",
          "K080561",
          "K080469",
          "K020828",
          "K022329",
          "K023597",
          "K972162",
          "K990431",
          "K042731",
          "K964098",
          "K980240",
          "K221355",
          "K143534",
          "K964185",
          "K964020",
          "K031297",
          "K213510",
          "K981297",
          "K200199",
          "K072794",
          "K240479",
          "K983875",
          "K100321",
          "K023891"
        ],
        "pma_number": [
          "P850009"
        ],
        "registration_number": [
          "3011989923",
          "1036362",
          "8020888",
          "2517506",
          "3007111389",
          "3012963943",
          "2432235",
          "3004192065",
          "8031673",
          "3005622096",
          "1319681",
          "2250051",
          "2020726",
          "1643621",
          "3002642396",
          "3000308930",
          "2122870",
          "9610126",
          "1219913",
          "2032839",
          "3005529799",
          "9612316",
          "2521625",
          "3005360469",
          "3014643041",
          "3006198300",
          "3002809144",
          "3005333358",
          "3002806944",
          "3002895169"
        ],
        "fei_number": [
          "3011989923",
          "3002806559",
          "1036362",
          "2517506",
          "3007111389",
          "3012963943",
          "2432235",
          "3004192065",
          "3005622096",
          "3007019572",
          "2250051",
          "2020726",
          "1643621",
          "3002642396",
          "1000136573",
          "3004185580",
          "3000308930",
          "3005670738",
          "2122870",
          "1219913",
          "3005529799",
          "2967",
          "3002808328",
          "2521625",
          "3014643041",
          "3006198300",
          "3002809144",
          "3005333358",
          "3002806944",
          "3002895169"
        ]
      },
      "review_panel": "IM",
      "medical_specialty": "IM",
      "device_name": "Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Immunology",
      "device_class": "2",
      "definition": "",
      "regulation_number": "866.6010",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}