{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Rehovot",
      "advisory_committee_description": "Immunology",
      "address_1": "3 Pekeris St.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MMW",
      "openfda": {
        "device_name": "System, Test, Tumor Marker, Monitoring, Bladder",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6010",
        "device_class": "2",
        "registration_number": [
          "1221359",
          "3012885391",
          "3004530258",
          "3016838963",
          "2435505"
        ],
        "fei_number": [
          "1221359",
          "3012885391",
          "3004530258",
          "1000119795",
          "3016838963"
        ]
      },
      "zip_code": "7660203",
      "applicant": "Nucleix , Ltd.",
      "decision_date": "2023-05-04",
      "decision_code": "SESE",
      "country_code": "IL",
      "device_name": "Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C",
      "advisory_committee": "IM",
      "contact": "Shmulik  Adler",
      "expedited_review_flag": "",
      "k_number": "K203245",
      "state": "",
      "date_received": "2020-11-03",
      "review_advisory_committee": "MG",
      "postal_code": "7660203",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}