{
  "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": "Alvear",
      "advisory_committee_description": "General Hospital",
      "address_1": "Ruta Nacional # 9, Km 280, Parque Industrial Micropi",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "FRC",
      "openfda": {
        "registration_number": [
          "2029076",
          "3004634710",
          "3013557562",
          "3036504234",
          "3038718579",
          "3013667284",
          "3030626857",
          "1416605",
          "3013298431",
          "3031757047",
          "2183301",
          "3011061109",
          "3009968482",
          "3014579161",
          "3031841433",
          "3013145340",
          "3004080920",
          "3043226252",
          "2434982",
          "3012723641",
          "3014421917",
          "2028456",
          "8030087",
          "1720309",
          "3009609218",
          "2432141",
          "2133641",
          "3016678045",
          "3012421607",
          "1319130",
          "3000251274",
          "3012494290",
          "2410251",
          "9611959",
          "2084725",
          "3003476474",
          "3017524825",
          "3030733800",
          "3042272797",
          "3016075971",
          "3015392401",
          "3007412809"
        ],
        "fei_number": [
          "3004634710",
          "3013557562",
          "3036504234",
          "3038718579",
          "3013667284",
          "3030626857",
          "1416605",
          "3002677549",
          "3013298431",
          "3031757047",
          "2183301",
          "3005343391",
          "3011061109",
          "3009968482",
          "3014579161",
          "3031841433",
          "3013145340",
          "3004080920",
          "1000125215",
          "3043226252",
          "2434982",
          "3014421917",
          "3009609218",
          "2432141",
          "1720309",
          "1000160630",
          "3016678045",
          "3012421607",
          "3003662624",
          "1319130",
          "3000203466",
          "3000251274",
          "3012494290",
          "3014534",
          "2410251",
          "3003476474",
          "3017524825",
          "3030733800",
          "3042272797",
          "3016075971",
          "3015392401",
          "3007412809"
        ],
        "device_name": "Indicator, Biological Sterilization Process",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.2800",
        "device_class": "2"
      },
      "zip_code": "2130",
      "applicant": "Terragene S.A.",
      "decision_date": "2019-09-13",
      "decision_code": "SESE",
      "country_code": "AR",
      "device_name": "Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye",
      "advisory_committee": "HO",
      "contact": "Maria Victoria Rocha",
      "expedited_review_flag": "",
      "k_number": "K191021",
      "state": "",
      "date_received": "2019-04-17",
      "review_advisory_committee": "HO",
      "postal_code": "2130",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}