{
  "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": "Newark",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "500 Gbc Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "JIT",
      "openfda": {
        "registration_number": [
          "3033967997",
          "3007662974",
          "3008344661",
          "1036362",
          "8020888",
          "1219029",
          "3003539867",
          "3027977508",
          "2915274",
          "2432235",
          "3004192065",
          "3014607865",
          "3005625991",
          "9610806",
          "3009189893",
          "3003522182",
          "2032087",
          "3003561301",
          "3003559191",
          "8043909",
          "2050012",
          "3003982601",
          "1220972",
          "3003030793",
          "9612316",
          "1218959",
          "8032314",
          "1063851",
          "3003951180",
          "2029372",
          "2150138",
          "9610529",
          "3007111389",
          "2032900",
          "3003422726",
          "8043889",
          "3016438761",
          "1221361",
          "3003871639",
          "3005847079",
          "1319808",
          "3003419906",
          "1643621",
          "3002642396",
          "2435505",
          "3000308930",
          "1827821",
          "2122870",
          "3029973107",
          "8023018",
          "3005529799",
          "2245451",
          "9614373",
          "3003423869",
          "3010421384",
          "3014643041",
          "3006198300",
          "3012348571",
          "2025099",
          "3002806944",
          "8021924",
          "9611444",
          "3002895169",
          "1181055",
          "2084025",
          "3010939897",
          "1319809",
          "3004493545",
          "3009518015",
          "2026994",
          "3012963943",
          "3003593973",
          "1415939",
          "9610987",
          "3005622096",
          "3014353045",
          "9681576",
          "3004875840",
          "3032705",
          "9616673",
          "9710337",
          "3003460426",
          "3004434070",
          "3007118747",
          "3012289015",
          "1219913",
          "9613959",
          "3013059683",
          "1221645",
          "3000148879",
          "8020316",
          "9610099",
          "3002809144",
          "3005333358",
          "3011926203",
          "2085064",
          "3011989923",
          "3037000637",
          "2517506",
          "1319436",
          "9610746",
          "3021841051",
          "1616487",
          "8031673",
          "1050138",
          "1319681",
          "2050010",
          "2250051",
          "2155",
          "2182595",
          "3009711478",
          "1832816",
          "3013660430",
          "3005094123",
          "3014279513",
          "1000403749",
          "3002637618",
          "9681753",
          "9610126",
          "2431530",
          "3012240236",
          "1181121",
          "2521625",
          "2030861",
          "3003985394",
          "3012471076",
          "3002694097",
          "9680746"
        ],
        "fei_number": [
          "3033967997",
          "3007662974",
          "3008344661",
          "3002806559",
          "1036362",
          "1219029",
          "3004445302",
          "3027977508",
          "1000305841",
          "2432235",
          "3004192065",
          "2915274",
          "3014607865",
          "3005625991",
          "3009189893",
          "3003522182",
          "3003561301",
          "3002701146",
          "3003559191",
          "2050012",
          "3003982601",
          "1220972",
          "3007981058",
          "3003030793",
          "1000120319",
          "3003355251",
          "1218959",
          "3003951180",
          "2150138",
          "3002806557",
          "3007111389",
          "3000215862",
          "3003422726",
          "3016438761",
          "1221361",
          "3006769061",
          "3003871639",
          "3007019572",
          "3005847079",
          "3003419906",
          "1643621",
          "3002642396",
          "3000308930",
          "1000306617",
          "1827821",
          "2122870",
          "3029973107",
          "3005529799",
          "3002808328",
          "2245451",
          "3010421384",
          "3003423869",
          "3014643041",
          "3006198300",
          "3012348571",
          "3002806944",
          "3002485711",
          "3002895169",
          "1181055",
          "2084025",
          "3000303338",
          "3010939897",
          "3002806778",
          "3002808140",
          "3004493545",
          "3002808340",
          "3009518015",
          "2026994",
          "3012963943",
          "3003593973",
          "1415939",
          "3005622096",
          "3002806560",
          "3014353045",
          "3004875840",
          "3002546385",
          "1000136573",
          "3003460426",
          "3004434070",
          "1000305840",
          "3007118747",
          "3012289015",
          "3002806809",
          "1000206808",
          "1219913",
          "3003206796",
          "3013059683",
          "1221645",
          "3000148879",
          "1000119795",
          "3002807272",
          "3002809144",
          "3005333358",
          "3011926203",
          "3011989923",
          "3002807423",
          "3037000637",
          "3001644026",
          "2517506",
          "3002676602",
          "3021841051",
          "1616487",
          "3002807710",
          "1050138",
          "3003179344",
          "2050010",
          "3002808301",
          "1000442352",
          "2250051",
          "2155",
          "2182595",
          "3009711478",
          "1832816",
          "3002808498",
          "3013660430",
          "3005094123",
          "3014279513",
          "1000403749",
          "3002637618",
          "1000135102",
          "2431530",
          "3012240236",
          "1181121",
          "2967",
          "2521625",
          "3003985394",
          "3012471076",
          "3002694097"
        ],
        "device_name": "Calibrator, Secondary",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1150",
        "device_class": "2"
      },
      "zip_code": "19702",
      "applicant": "Siemens Healthcare Diagnostics",
      "decision_date": "2013-04-05",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)",
      "advisory_committee": "CH",
      "contact": "ANNA MARIE  ENNIS",
      "expedited_review_flag": "",
      "k_number": "K130698",
      "state": "DE",
      "date_received": "2013-03-14",
      "review_advisory_committee": "CH",
      "postal_code": "19702",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Abbreviated"
    }
  ]
}