{
  "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": "Miami",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "7522 NW 55th St.",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "CGX",
      "openfda": {
        "registration_number": [
          "3004192065",
          "8020316",
          "3006716639",
          "2030861",
          "2517506",
          "9616671",
          "1818910",
          "3016438761",
          "3005333358",
          "3006198300",
          "9610633",
          "3011989923",
          "9680746",
          "3004493545",
          "2085064",
          "3003030793",
          "1616487",
          "3002809144",
          "3010825766",
          "3023162659",
          "1220972",
          "3000148879",
          "3005094123",
          "3003593973",
          "9610126",
          "1219029",
          "3003795116",
          "1181121",
          "2939693",
          "3002637618",
          "1832216",
          "1827821",
          "2247288",
          "2050012",
          "1063851",
          "9610529",
          "3004875840",
          "2050010",
          "2432235"
        ],
        "fei_number": [
          "3004192065",
          "3006716639",
          "2517506",
          "1818910",
          "3016438761",
          "3005333358",
          "3006198300",
          "3004493545",
          "3011989923",
          "3003030793",
          "1616487",
          "3002809144",
          "1000135102",
          "3010825766",
          "3023162659",
          "3002806559",
          "3000148879",
          "3005094123",
          "1220972",
          "3003593973",
          "1219029",
          "3003795116",
          "1181121",
          "2939693",
          "1000442352",
          "3002806693",
          "3002854251",
          "3002637618",
          "1832216",
          "1000122044",
          "1827821",
          "3000215862",
          "1000206808",
          "2050012",
          "3002806809",
          "3004875840",
          "2050010",
          "3002806560",
          "2432235"
        ],
        "device_name": "Alkaline Picrate, Colorimetry, Creatinine",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1225",
        "device_class": "2"
      },
      "zip_code": "33166",
      "applicant": "Biochemical Trade, Inc.",
      "decision_date": "1991-02-13",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "CREATININE (RATE) REAGENT SET",
      "advisory_committee": "CH",
      "contact": "ALEJO  ROY",
      "expedited_review_flag": "",
      "k_number": "K905619",
      "state": "FL",
      "date_received": "1990-12-14",
      "review_advisory_committee": "CH",
      "postal_code": "33166",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}