{
  "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": "Center Valley",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "3500 Corporate Pkway",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "CIG",
      "openfda": {
        "registration_number": [
          "8020316",
          "3006198300",
          "3006716639",
          "2431530",
          "8040374",
          "2432235",
          "3016438761",
          "9610529",
          "2517506",
          "9680746",
          "3002807968",
          "1217058",
          "1181121",
          "3021841051",
          "2939693",
          "3010825766",
          "1181055",
          "1219029",
          "3005146313",
          "1827821",
          "3007662974",
          "3003593973",
          "3002809144",
          "3012963943",
          "1220972",
          "2050012",
          "3000148879",
          "2247288",
          "2050010",
          "2030861",
          "3013513377",
          "3002642396",
          "2250051",
          "3000308930",
          "3005333358",
          "1217183",
          "1616487",
          "1319681",
          "9610126",
          "1319809",
          "3005094123",
          "3004493545",
          "3003795116",
          "3013660430",
          "3011989923",
          "1649661",
          "3037000637",
          "1832216",
          "2085064"
        ],
        "fei_number": [
          "3006198300",
          "3006716639",
          "2431530",
          "1000122044",
          "3000215862",
          "1000305840",
          "2432235",
          "3016438761",
          "2517506",
          "3002807968",
          "1217058",
          "1181121",
          "3021841051",
          "2939693",
          "3010825766",
          "1181055",
          "1219029",
          "5864",
          "3005146313",
          "1827821",
          "3007662974",
          "1000135102",
          "3003593973",
          "3002809144",
          "3012963943",
          "1220972",
          "3002806809",
          "2050012",
          "3000148879",
          "2050010",
          "3013513377",
          "3002642396",
          "2250051",
          "3000308930",
          "3005333358",
          "1217183",
          "1616487",
          "3004493545",
          "3005094123",
          "3003795116",
          "3002806559",
          "3013660430",
          "3011989923",
          "3037000637",
          "3001451797",
          "3002806560",
          "1832216",
          "1000206808",
          "1000136573"
        ],
        "device_name": "Diazo Colorimetry, Bilirubin",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1110",
        "device_class": "2"
      },
      "zip_code": "18034",
      "applicant": "Olympus Life Science Research Europa GmbH (Europa)",
      "decision_date": "2008-09-05",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181",
      "advisory_committee": "CH",
      "contact": "STEPHANIE G DONNELLY",
      "expedited_review_flag": "",
      "k_number": "K080435",
      "state": "PA",
      "date_received": "2008-02-19",
      "review_advisory_committee": "CH",
      "postal_code": "18034",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}