{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Dundee",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "Luna Pl., The Technology Park",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "CDD",
      "openfda": {
        "registration_number": [
          "3004192065",
          "2517506",
          "2432235",
          "3007111389",
          "3005333358",
          "3006198300",
          "3022178699",
          "3009518015",
          "3005655287",
          "3011989923",
          "9680746",
          "3002806944",
          "3006677029",
          "3002809144",
          "2032682",
          "3005094123",
          "9610126",
          "8020888",
          "1036362",
          "8032314",
          "8031673",
          "2032839",
          "2020726",
          "3033967997",
          "2122870",
          "3005529799",
          "9612316",
          "2182595",
          "3015969360",
          "1219913",
          "1319681"
        ],
        "fei_number": [
          "3004192065",
          "3002808140",
          "2517506",
          "2432235",
          "3007111389",
          "3005333358",
          "3007019572",
          "3006198300",
          "3022178699",
          "2967",
          "3005655287",
          "3011989923",
          "3002806944",
          "3009518015",
          "3006677029",
          "3002809144",
          "3002806559",
          "3005094123",
          "1036362",
          "1000136573",
          "3004185580",
          "3003952975",
          "2020726",
          "1000206808",
          "3033967997",
          "2122870",
          "3005529799",
          "3002808328",
          "2182595",
          "3015969360",
          "1219913"
        ],
        "device_name": "Radioassay, Vitamin B12",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1810",
        "device_class": "2"
      },
      "zip_code": "DD2 1XA",
      "applicant": "Axis-Shield Diagnostics, Ltd.",
      "decision_date": "2017-10-27",
      "decision_code": "SESE",
      "country_code": "GB",
      "device_name": "ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay",
      "advisory_committee": "CH",
      "contact": "Claire  Dora",
      "expedited_review_flag": "",
      "k_number": "K172133",
      "state": "",
      "date_received": "2017-07-14",
      "review_advisory_committee": "CH",
      "postal_code": "DD2 1XA",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
    }
  ]
}