{
  "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": "Newark",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "500 Gbc Dr.,",
      "address_2": "M/S 514, P.O. Box 6101",
      "statement_or_summary": "Summary",
      "product_code": "CDT",
      "openfda": {
        "device_name": "Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1705",
        "device_class": "1",
        "registration_number": [
          "3011989923",
          "9610529",
          "3007662974",
          "3003795116",
          "2247288",
          "1319809",
          "3004493545",
          "2517506",
          "3012963943",
          "1616487",
          "2432235",
          "3016438761",
          "3003593973",
          "2050010",
          "1319681",
          "3014325803",
          "2250051",
          "3002642396",
          "3013660430",
          "3000308930",
          "3006644620",
          "1827821",
          "2029015",
          "9610126",
          "2050012",
          "3006716639",
          "3021010433",
          "3000148879",
          "1220972",
          "1181121",
          "8020316",
          "1832216",
          "3010825766",
          "1063851",
          "2030861",
          "3006198300",
          "3005333358",
          "9680746",
          "2085064"
        ],
        "fei_number": [
          "3011989923",
          "3007662974",
          "3003795116",
          "3002806559",
          "3004493545",
          "2517506",
          "3000215862",
          "3012963943",
          "1616487",
          "2432235",
          "3016438761",
          "3003593973",
          "2050010",
          "3002806560",
          "3014325803",
          "1000442352",
          "2250051",
          "1000122044",
          "1000160458",
          "3002642396",
          "3013660430",
          "1000136573",
          "3000308930",
          "3006644620",
          "1827821",
          "1000305840",
          "3002806809",
          "1000206808",
          "1000135102",
          "2050012",
          "3006716639",
          "3021010433",
          "3000148879",
          "1220972",
          "1181121",
          "1832216",
          "3010825766",
          "3006198300",
          "3005333358"
        ]
      },
      "zip_code": "19714",
      "applicant": "Dade Behring, Inc.",
      "decision_date": "2005-01-18",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE",
      "advisory_committee": "CH",
      "contact": "STANLEY  GORAK",
      "expedited_review_flag": "",
      "k_number": "K043546",
      "state": "DE",
      "date_received": "2004-12-23",
      "review_advisory_committee": "CH",
      "postal_code": "19714",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
    }
  ]
}