{
  "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",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "NRS",
      "openfda": {
        "registration_number": [
          "1938173",
          "3004153557",
          "3014150341"
        ],
        "fei_number": [
          "1938173",
          "3004153557",
          "3014150341"
        ],
        "k_number": [
          "K040898"
        ]
      },
      "review_panel": "HE",
      "medical_specialty": "HE",
      "device_name": "Control Material, Blood Circulating Epithelial Cancer Cell",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Hematology",
      "device_class": "2",
      "definition": "The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells.  This device is used as an assay quality control to ensure that sample detection and identification systems are able to detect circulating epithelial tumor cells.",
      "regulation_number": "864.8625",
      "implant_flag": "N",
      "submission_type_id": "4"
    }
  ]
}