{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 28
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Portland",
      "advisory_committee_description": "Clinical Toxicology",
      "address_1": "4432 Se16th.Ave.",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "LGR",
      "openfda": {
        "registration_number": [
          "3006198300",
          "1219913",
          "3003871639",
          "3033967997",
          "2432235",
          "3005333358",
          "8020888",
          "3002809144"
        ],
        "fei_number": [
          "3006198300",
          "1219913",
          "3003871639",
          "3033967997",
          "2432235",
          "3005333358",
          "3007019572",
          "3002809144"
        ],
        "device_name": "Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3350",
        "device_class": "2"
      },
      "zip_code": "97202",
      "applicant": "Innotron of Oregon, Inc.",
      "decision_date": "1989-10-31",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET",
      "advisory_committee": "TX",
      "contact": "CRAIG  SMART",
      "expedited_review_flag": "",
      "k_number": "K895827",
      "state": "OR",
      "date_received": "1989-10-02",
      "review_advisory_committee": "TX",
      "postal_code": "97202",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}