{
  "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": "Indianapolis",
      "advisory_committee_description": "Immunology",
      "address_1": "9115 Hague Rd.",
      "address_2": "P.O. Box 50416",
      "statement_or_summary": "Summary",
      "product_code": "DCN",
      "openfda": {
        "registration_number": [
          "3009491259",
          "9614373",
          "3006198300",
          "1641328",
          "2435505",
          "2432235",
          "2250030",
          "9610529",
          "2517506",
          "9680746",
          "3029973107",
          "2939693",
          "3010825766",
          "9610987",
          "3012471076",
          "3014353045",
          "2029372",
          "2050012",
          "2032682",
          "2050010",
          "1616487",
          "3004493545",
          "9610126",
          "1036362",
          "3002806944",
          "3003795116",
          "3014607865",
          "2020726",
          "1649661",
          "3005174594",
          "1832216",
          "9610806",
          "2085064"
        ],
        "fei_number": [
          "3009491259",
          "3006198300",
          "1641328",
          "2432235",
          "2250030",
          "1000119795",
          "2517506",
          "3029973107",
          "2939693",
          "3010825766",
          "3012471076",
          "3014353045",
          "1000135102",
          "2050012",
          "2050010",
          "1000306617",
          "3003952975",
          "1616487",
          "3004493545",
          "1036362",
          "3002806944",
          "3003795116",
          "3002806559",
          "3014607865",
          "2020726",
          "3001644026",
          "3001451797",
          "3005174594",
          "3002808340",
          "3002807710",
          "3002806560",
          "1832216",
          "1000206808"
        ],
        "device_name": "System, Test, C-Reactive Protein",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5270",
        "device_class": "2"
      },
      "zip_code": "46250",
      "applicant": "Roche Diagnostics Corp.",
      "decision_date": "2009-03-18",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "C-REACTIVE PROTEIN (LATEX)",
      "advisory_committee": "IM",
      "contact": "KATHIE J GOODWIN",
      "expedited_review_flag": "",
      "k_number": "K083444",
      "state": "IN",
      "date_received": "2008-11-21",
      "review_advisory_committee": "IM",
      "postal_code": "46250",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}