{
  "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": "St. Louis",
      "advisory_committee_description": "Hematology",
      "address_1": "Post Office Box 14508",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "GGP",
      "openfda": {
        "device_name": "Test, Qualitative And Quantitative Factor Deficiency",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7290",
        "device_class": "2",
        "registration_number": [
          "1721937",
          "1618982",
          "9710666",
          "2518152",
          "3003485232",
          "2183608",
          "3003601075",
          "1835316",
          "9610806",
          "1217183",
          "2245451",
          "3008386529",
          "3037000637",
          "3004737529",
          "2431530",
          "3003691680",
          "3004075036",
          "3004434070",
          "8043599",
          "9610746",
          "2432235"
        ],
        "fei_number": [
          "3003565434",
          "1618982",
          "2518152",
          "3003485232",
          "2183608",
          "3003601075",
          "1217183",
          "2245451",
          "3000210416",
          "3008386529",
          "3037000637",
          "1000117401",
          "3004737529",
          "2431530",
          "3003691680",
          "3002806557",
          "3005917516",
          "3004075036",
          "3004434070",
          "3001644026",
          "2432235"
        ]
      },
      "zip_code": "63278",
      "applicant": "Sigma Chemical Co.",
      "decision_date": "1986-05-29",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765",
      "advisory_committee": "HE",
      "contact": "LEO  BRESSLER",
      "expedited_review_flag": "",
      "k_number": "K861048",
      "state": "MO",
      "date_received": "1986-03-19",
      "review_advisory_committee": "HE",
      "postal_code": "63278",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}