{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Golstrup",
      "advisory_committee_description": "Hematology",
      "address_1": "Produktionsvej 42",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MYA",
      "openfda": {
        "registration_number": [
          "3012214605",
          "2022180",
          "1831638",
          "3004140393",
          "2916205",
          "2028492",
          "3010939897",
          "3008776165",
          "3009189893",
          "3004859032"
        ],
        "fei_number": [
          "3012214605",
          "2022180",
          "1000125183",
          "3004140393",
          "2916205",
          "3010939897",
          "2936532",
          "1831638",
          "3009189893",
          "3004859032"
        ],
        "device_name": "Immunohistochemistry Antibody Assay, Estrogen Receptor",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.1860",
        "device_class": "2"
      },
      "zip_code": "2600",
      "applicant": "Dako Denmark A/S",
      "decision_date": "2017-12-21",
      "decision_code": "SESE",
      "country_code": "DK",
      "device_name": "FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)",
      "advisory_committee": "HE",
      "contact": "Lasse Post Moller",
      "expedited_review_flag": "",
      "k_number": "K170028",
      "state": "",
      "date_received": "2017-01-03",
      "review_advisory_committee": "PA",
      "postal_code": "2600",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}