{
  "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": "Columbia",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "9033 Red Branch Rd.",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "CDQ",
      "openfda": {
        "registration_number": [
          "8040374",
          "8020316",
          "3006716639",
          "2030861",
          "2517506",
          "3016438761",
          "3005333358",
          "3006198300",
          "3013660430",
          "3004493545",
          "1319436",
          "3011989923",
          "9680746",
          "2085064",
          "1616487",
          "3010825766",
          "2221819",
          "1220972",
          "3000148879",
          "3003593973",
          "9610126",
          "3003795116",
          "1217183",
          "1181121",
          "1832216",
          "3009156722",
          "3037000637",
          "1827821",
          "2431530",
          "2050012",
          "1063851",
          "3007603826",
          "9610529",
          "2050010",
          "3007662974",
          "2432235"
        ],
        "fei_number": [
          "3006716639",
          "2517506",
          "3016438761",
          "3005333358",
          "3006198300",
          "3013660430",
          "5864",
          "3011989923",
          "3004493545",
          "1616487",
          "1000135102",
          "3010825766",
          "2221819",
          "3002806559",
          "3000148879",
          "1220972",
          "3003593973",
          "1000120319",
          "3003795116",
          "1217183",
          "1181121",
          "1000442352",
          "1832216",
          "3009156722",
          "3037000637",
          "1827821",
          "3000215862",
          "2431530",
          "1000206808",
          "2050012",
          "3002806809",
          "3007603826",
          "2050010",
          "3007662974",
          "3002806560",
          "2432235"
        ],
        "device_name": "Urease And Glutamic Dehydrogenase, Urea Nitrogen",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1770",
        "device_class": "2"
      },
      "zip_code": "21045",
      "applicant": "Hemagen Diagnostics, Inc.",
      "decision_date": "2001-10-15",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "RAICHEM BUN RATE REAGENT",
      "advisory_committee": "CH",
      "contact": "JOSE A MONTANEZ",
      "expedited_review_flag": "",
      "k_number": "K012649",
      "state": "MD",
      "date_received": "2001-08-13",
      "review_advisory_committee": "CH",
      "postal_code": "21045",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}