{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 7
    }
  },
  "results": [
    {
      "proprietary_name": [
        "PATHFAST CK-MB-II",
        "PATHFAST Myo-II",
        "PATHFAST Sample Diluent 1"
      ],
      "establishment_type": [
        "Complaint File Establishment per 21 CFR 820.198",
        "Develop Specifications But Do Not Manufacture At This Facility"
      ],
      "registration": {
        "registration_number": "3029973107",
        "fei_number": "3029973107",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2027",
        "name": "PHC Corporation",
        "address_line_1": "1460-6 Aza-Mitodai, Mito",
        "address_line_2": "",
        "city": "Tako-machi Katori-gun Chiba",
        "state_code": "",
        "iso_country_code": "JP",
        "zip_code": "",
        "postal_code": "2892247",
        "us_agent": {
          "name": "Timothy Huang",
          "business_name": "",
          "bus_phone_area_code": "757",
          "bus_phone_num": "5280196",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "tim.huang@us.phchd.com",
          "address_line_1": "41 University Dr Ste 400 Ofc 403",
          "address_line_2": "",
          "city": "Newtown",
          "state_code": "PA",
          "iso_country_code": "US",
          "zip_code": "18940",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "PHC Corporation",
          "owner_operator_number": "9052268",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "2131-1 MINAMIGATA",
            "address_2": "",
            "city": "TOON",
            "state_code": "JP-38",
            "state_province": "Ehime",
            "iso_country_code": "JP",
            "postal_code": "791-0395"
          }
        }
      },
      "pma_number": "",
      "k_number": "K081360",
      "products": [
        {
          "product_code": "DDR",
          "created_date": "2023-11-16",
          "owner_operator_number": "9052268",
          "exempt": "",
          "openfda": {
            "device_name": "Myoglobin, Antigen, Antiserum, Control",
            "medical_specialty_description": "Immunology",
            "regulation_number": "866.5680",
            "device_class": "2"
          }
        },
        {
          "product_code": "JIT",
          "created_date": "2023-11-16",
          "owner_operator_number": "9052268",
          "exempt": "",
          "openfda": {
            "device_name": "Calibrator, Secondary",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1150",
            "device_class": "2"
          }
        },
        {
          "product_code": "JHX",
          "created_date": "2023-11-16",
          "owner_operator_number": "9052268",
          "exempt": "",
          "openfda": {
            "device_name": "Fluorometric Method, Cpk Or Isoenzymes",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1215",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}