{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 14
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Accu-Chek Performa test strips",
        "Accu-Chek Guide Blood Glucose Monitoring System",
        "Accu-Chek Guide test strips",
        "Accu-Chek Inform II test strips",
        "Accu-Chek Aviva test strips",
        "Accu-Chek Instant test strips"
      ],
      "establishment_type": [
        "Manufacture Device in the United States for Export Only"
      ],
      "registration": {
        "registration_number": "3011393376",
        "fei_number": "3011393376",
        "status_code": "1",
        "initial_importer_flag": "Y",
        "reg_expiry_date_year": "2027",
        "name": "ROCHE DIABETES CARE, INC.",
        "address_line_1": "9115 Hague Road",
        "address_line_2": "",
        "city": "Indianapolis",
        "state_code": "IN",
        "iso_country_code": "US",
        "zip_code": "46250",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "Roche Diagnostics Operations Inc.",
          "owner_operator_number": "9039767",
          "official_correspondent": {
            "first_name": "Brian",
            "middle_initial": "",
            "last_name": "Frazier",
            "subaccount_company_name": "",
            "phone_number": "x-317-3194485-x"
          },
          "contact_address": {
            "address_1": "9115 Hague Road",
            "address_2": "",
            "city": "Indianapolis",
            "state_code": "IN",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "46250"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "LFR",
          "created_date": "2018-05-07",
          "owner_operator_number": "9039767",
          "exempt": "",
          "openfda": {
            "device_name": "Glucose Dehydrogenase, Glucose",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1345",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}