{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Espoo",
      "advisory_committee_description": "Immunology",
      "address_1": "Koivu-Mankkaan Tie 6",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "DCK",
      "openfda": {
        "registration_number": [
          "1181055",
          "3011989923",
          "2084025",
          "1319809",
          "3004493545",
          "2032900",
          "3005984081",
          "3012963943",
          "2432235",
          "3014607865",
          "3003871639",
          "2050010",
          "1319681",
          "1319808",
          "2250051",
          "3019906",
          "3002800697",
          "3002642396",
          "3022178699",
          "1000403749",
          "9610102",
          "3000308930",
          "1827821",
          "9681753",
          "9613069",
          "9610126",
          "2050012",
          "3026565854",
          "3000148879",
          "1220972",
          "2431980",
          "2245285",
          "8020316",
          "1832216",
          "3017505309",
          "9614373",
          "3005360469",
          "2030861",
          "3006198300",
          "3012471076",
          "3002809144",
          "3005333358",
          "2029372",
          "2025099",
          "9680746",
          "2085064"
        ],
        "fei_number": [
          "1181055",
          "3011989923",
          "2084025",
          "3000303338",
          "3002806559",
          "3004493545",
          "3002808340",
          "3000215862",
          "3005984081",
          "3004445302",
          "3012963943",
          "1000305841",
          "2432235",
          "3014607865",
          "3003871639",
          "2050010",
          "2250051",
          "3019906",
          "3002800697",
          "3002642396",
          "3022178699",
          "1000403749",
          "1000136573",
          "3000308930",
          "1000305840",
          "1827821",
          "1000306617",
          "3005670738",
          "3002806809",
          "1000206808",
          "3003045237",
          "1000135102",
          "2050012",
          "3026565854",
          "3000148879",
          "1220972",
          "3007981058",
          "2431980",
          "2245285",
          "1832216",
          "3017505309",
          "3006198300",
          "3012471076",
          "3002809144",
          "3005333358",
          "3002807786"
        ],
        "device_name": "C-Reactive Protein, Antigen, Antiserum, And Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5270",
        "device_class": "2"
      },
      "zip_code": "02200",
      "applicant": "Orion Diagnostica, Div. Orion Corp.",
      "decision_date": "2002-12-03",
      "decision_code": "SESE",
      "country_code": "FI",
      "device_name": "ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257",
      "advisory_committee": "IM",
      "contact": "ANNIKKA  RANTAMA",
      "expedited_review_flag": "",
      "k_number": "K022176",
      "state": "",
      "date_received": "2002-07-03",
      "review_advisory_committee": "IM",
      "postal_code": "02200",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}