{
  "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": "Tarrytown",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "511 Benedict Ave.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "CFR",
      "openfda": {
        "registration_number": [
          "3011989923",
          "3009156722",
          "9610529",
          "3007662974",
          "3003795116",
          "3007603826",
          "2247288",
          "3004493545",
          "3016244760",
          "2517506",
          "2221819",
          "2032900",
          "1616487",
          "2432235",
          "3004192065",
          "3016438761",
          "1415939",
          "2050010",
          "3004438098",
          "9614673",
          "3013660430",
          "1000256526",
          "1827821",
          "9610942",
          "9610126",
          "2050012",
          "3006716639",
          "3000148879",
          "1220972",
          "1181121",
          "8020316",
          "1832216",
          "3004378326",
          "3010825766",
          "1063851",
          "2030861",
          "3006198300",
          "3010324880",
          "3002809144",
          "3005333358",
          "3020917535",
          "3009880320",
          "9680746",
          "2085064"
        ],
        "fei_number": [
          "3011989923",
          "3009156722",
          "3007662974",
          "3003795116",
          "3002806559",
          "3007603826",
          "3004493545",
          "3016244760",
          "2517506",
          "2221819",
          "3000215862",
          "3004445302",
          "1616487",
          "2432235",
          "3004192065",
          "3016438761",
          "1415939",
          "2050010",
          "3002806560",
          "1000442352",
          "1000122044",
          "3004438098",
          "3007262384",
          "3013660430",
          "1000256526",
          "1827821",
          "3002806809",
          "1000206808",
          "1000135102",
          "2050012",
          "3006716639",
          "3000148879",
          "1220972",
          "1181121",
          "1832216",
          "3004378326",
          "3010825766",
          "3006198300",
          "3010324880",
          "3002809144",
          "3009880320",
          "3003559576",
          "3005333358",
          "3020917535"
        ],
        "device_name": "Hexokinase, Glucose",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1345",
        "device_class": "2"
      },
      "zip_code": "10591",
      "applicant": "Bayer Corp.",
      "decision_date": "2001-11-20",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY",
      "advisory_committee": "CH",
      "contact": "KENNETH T EDDS",
      "expedited_review_flag": "",
      "k_number": "K011963",
      "state": "NY",
      "date_received": "2001-06-22",
      "review_advisory_committee": "CH",
      "postal_code": "10591",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}