{
  "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": "Park Ridge",
      "advisory_committee_description": "Immunology",
      "address_1": "674 Busse Hwy.",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "DHN",
      "openfda": {
        "registration_number": [
          "1181055",
          "2918768",
          "3003825930",
          "2016706",
          "3015376545",
          "3032523590",
          "2026994",
          "2915274",
          "3026753391",
          "2182595",
          "2914537",
          "3032705",
          "3004973408",
          "3007118747",
          "3003268355",
          "3010127294",
          "1419968",
          "3007361513",
          "3012348571",
          "2029372",
          "2242436"
        ],
        "fei_number": [
          "1181055",
          "2918768",
          "3003825930",
          "2016706",
          "3015376545",
          "3032523590",
          "2026994",
          "2915274",
          "3026753391",
          "2182595",
          "2914537",
          "3004973408",
          "3002701146",
          "1000306617",
          "3007118747",
          "3003268355",
          "3010127294",
          "1419968",
          "3007361513",
          "3012348571",
          "2242436"
        ],
        "device_name": "Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5100",
        "device_class": "2"
      },
      "zip_code": "60068",
      "applicant": "Bion Ent., Ltd.",
      "decision_date": "1987-08-17",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM",
      "advisory_committee": "IM",
      "contact": "EDWARD  NOWAKOWSKI",
      "expedited_review_flag": "",
      "k_number": "K872845",
      "state": "IL",
      "date_received": "1987-07-20",
      "review_advisory_committee": "IM",
      "postal_code": "60068",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}