{
  "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",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "JIS",
      "openfda": {
        "k_number": [
          "K832251",
          "K791315",
          "K872051",
          "K810587",
          "K994145",
          "K813478",
          "K871187",
          "K801287",
          "K822474",
          "K994168",
          "K862704",
          "K012878",
          "K822477",
          "K951964",
          "K022682",
          "K920809",
          "K840217",
          "K822332",
          "K895585",
          "K003969",
          "K032296",
          "K922646",
          "K970933",
          "K932555",
          "K810742",
          "K001002",
          "K930477",
          "K951585",
          "K822473",
          "K122126",
          "K801501",
          "K881693",
          "K951629",
          "K905820",
          "K032697",
          "K882726",
          "K810963",
          "K936201",
          "K994325",
          "K994114",
          "K801665",
          "K840220",
          "K954546",
          "K800206",
          "K861768",
          "K861891",
          "K940008",
          "K030964",
          "K963847",
          "K844235",
          "K770072",
          "K822232",
          "K821938",
          "K901113",
          "K921855",
          "K002760",
          "K011568",
          "K843110",
          "K000331",
          "K822476",
          "K823147",
          "K931834",
          "K921903",
          "K870379",
          "K842450",
          "K013126",
          "K964475",
          "K871185",
          "K841955",
          "K821813",
          "K861769",
          "K884168",
          "K001004",
          "K983640",
          "K861770",
          "K993219",
          "K032608",
          "K800062",
          "K840299",
          "K862453",
          "K810618",
          "K003941",
          "K855040",
          "K930501",
          "K792046",
          "K944701",
          "K922698",
          "K022901",
          "K002353",
          "K053104",
          "K852068",
          "K772025",
          "K802631",
          "K925877",
          "K871188",
          "K780467",
          "K001005",
          "K830283",
          "K905477",
          "K810091",
          "K821937",
          "K842449",
          "K812861",
          "K844581",
          "K001906",
          "K994169",
          "K813447",
          "K800588",
          "K030320",
          "K924904",
          "K030546",
          "K821061",
          "K922696",
          "K060266",
          "K810092",
          "K830137",
          "K061251",
          "K922699",
          "K895778",
          "K760806",
          "K010696",
          "K820698",
          "K910721",
          "K781853",
          "K813505",
          "K800042",
          "K871186",
          "K821934",
          "K810743",
          "K810867"
        ],
        "registration_number": [
          "1181055",
          "3011989923",
          "2084025",
          "3008344661",
          "3010939897",
          "1319809",
          "3037000637",
          "3002807722",
          "2517506",
          "1318354",
          "3004529019",
          "3003539867",
          "3007111389",
          "3004493545",
          "9610746",
          "3009518015",
          "3012963943",
          "2432235",
          "3004192065",
          "8031673",
          "3016698405",
          "3003871639",
          "3005625991",
          "1319681",
          "2050010",
          "1319808",
          "3003419906",
          "2250051",
          "9610806",
          "3004111573",
          "1717966",
          "3003522182",
          "3002642396",
          "3013660430",
          "3005094123",
          "3010830834",
          "1000403749",
          "3003561301",
          "3003749380",
          "3000308930",
          "8023024",
          "1827821",
          "2247288",
          "2122870",
          "9681753",
          "9610126",
          "1219913",
          "2050012",
          "1221645",
          "3000148879",
          "2431530",
          "3015171822",
          "1181121",
          "3005529799",
          "9612316",
          "3003453957",
          "8020316",
          "1832216",
          "9710666",
          "2245451",
          "9614373",
          "3003591759",
          "1063851",
          "2030861",
          "3006198300",
          "3012471076",
          "2434178",
          "3002809144",
          "3005333358",
          "9680746",
          "2085064",
          "1825740"
        ],
        "fei_number": [
          "1181055",
          "3011989923",
          "2084025",
          "3000303338",
          "3008344661",
          "3010939897",
          "3002806559",
          "3037000637",
          "3002807722",
          "2517506",
          "3002808340",
          "1318354",
          "3007111389",
          "3001644026",
          "3004529019",
          "3004493545",
          "3009518015",
          "3000215862",
          "3004525092",
          "3012963943",
          "1000305841",
          "3004192065",
          "2432235",
          "3016698405",
          "3006769061",
          "3003871639",
          "3005625991",
          "2050010",
          "1000442352",
          "3003419906",
          "2250051",
          "1000122044",
          "3004111573",
          "1717966",
          "3003522182",
          "3002642396",
          "3013660430",
          "3005094123",
          "1000403749",
          "3003561301",
          "3003749380",
          "1000136573",
          "3000308930",
          "1000305840",
          "1827821",
          "2122870",
          "3002806809",
          "1000206808",
          "1000135102",
          "1219913",
          "2050012",
          "1221645",
          "3000148879",
          "2431530",
          "3015171822",
          "1181121",
          "3005529799",
          "6387",
          "2967",
          "3003453957",
          "1832216",
          "3002808328",
          "2245451",
          "3003591759",
          "3006198300",
          "3012471076",
          "2434178",
          "3002809144",
          "3005333358",
          "3003565434",
          "3002806557",
          "1825740"
        ]
      },
      "review_panel": "CH",
      "medical_specialty": "CH",
      "device_name": "Calibrator, Primary",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Chemistry",
      "device_class": "2",
      "definition": "",
      "regulation_number": "862.1150",
      "implant_flag": "N",
      "submission_type_id": "4"
    }
  ]
}