{
  "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": 5
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Variant nbs Newborn Screening System"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "1000487132",
        "fei_number": "1000487132",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "OEM SYSTEMS CO. LTD.",
        "address_line_1": "84 MEKAWA MAKISHIMA-CHO",
        "address_line_2": "",
        "city": "UJI-SHI Ky?to",
        "state_code": "",
        "iso_country_code": "JP",
        "zip_code": "",
        "postal_code": "6110041",
        "us_agent": {
          "name": "Kenneth Block",
          "business_name": "Ken Block Consulting",
          "bus_phone_area_code": "972",
          "bus_phone_num": "4809554",
          "bus_phone_extn": "",
          "fax_area_code": "972",
          "fax_num": "7674325",
          "email_address": "k.block@kenblockconsulting.com",
          "address_line_1": "3400 N Central Expy Ste 100265",
          "address_line_2": "",
          "city": "Richardson",
          "state_code": "TX",
          "iso_country_code": "US",
          "zip_code": "75080",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "OEM SYSTEMS CO. LTD.",
          "owner_operator_number": "9050895",
          "official_correspondent": {
            "first_name": "Kenneth",
            "middle_initial": "",
            "last_name": "Block",
            "subaccount_company_name": "",
            "phone_number": "81-774-202481-x"
          },
          "contact_address": {
            "address_1": "84 MEKAWA MAKISHIMA-CHO",
            "address_2": "",
            "city": "UJI-SHI KYOTO",
            "state_code": "JP-NOTA",
            "state_province": "",
            "iso_country_code": "JP",
            "postal_code": "6110041"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "GKA",
          "created_date": "2023-01-26",
          "owner_operator_number": "9050895",
          "exempt": "",
          "openfda": {
            "device_name": "Abnormal Hemoglobin Quantitation",
            "medical_specialty_description": "Hematology",
            "regulation_number": "864.7415",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}