{
  "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": "2026-09-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 15
    }
  },
  "results": [
    {
      "proprietary_name": [
        "ReliOn Premier BLU Blood Glucose Monitoring System",
        "CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3011213605",
        "fei_number": "3011213605",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "i-SENS Songdo Factory",
        "address_line_1": "12, Harmony-ro 275beon-gil, Yeonsu-gu,",
        "address_line_2": "",
        "city": "Incheon",
        "state_code": "",
        "iso_country_code": "KR",
        "zip_code": "",
        "postal_code": "22014",
        "us_agent": {
          "name": "Yoon Ha Cha",
          "business_name": "i-SENS USA, Inc.",
          "bus_phone_area_code": "607",
          "bus_phone_num": "3771441",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "i-sens-usa@i-sens.com",
          "address_line_1": "3545 Lomita Blvd., Unit D",
          "address_line_2": "",
          "city": "Torrance",
          "state_code": "CA",
          "iso_country_code": "US",
          "zip_code": "90505",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "i-SENS, Inc.",
          "owner_operator_number": "9083763",
          "official_correspondent": {
            "first_name": "Han Wool",
            "middle_initial": "",
            "last_name": "Kim",
            "subaccount_company_name": "",
            "phone_number": "82-2-9100452-x"
          },
          "contact_address": {
            "address_1": "43, Banpo-daero 28-gil, Seocho-gu",
            "address_2": "",
            "city": "Seoul",
            "state_code": "KR-11",
            "state_province": "",
            "iso_country_code": "KR",
            "postal_code": "06646"
          }
        }
      },
      "pma_number": "",
      "k_number": "K170614",
      "products": [
        {
          "product_code": "NBW",
          "created_date": "2017-10-26",
          "owner_operator_number": "9083763",
          "exempt": "",
          "openfda": {
            "device_name": "System, Test, Blood Glucose, Over The Counter",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1345",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}