{
  "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": "Immunology",
      "address_1": "P.O. Box 6101",
      "address_2": "M/S 514",
      "statement_or_summary": "Summary",
      "product_code": "NIG",
      "openfda": {
        "device_name": "System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6010",
        "device_class": "2",
        "registration_number": [
          "8020888",
          "2517506",
          "3007111389",
          "3012963943",
          "2432235",
          "8031673",
          "1319681",
          "2250051",
          "2020726",
          "3002642396",
          "3000308930",
          "2122870",
          "9610126",
          "1219913",
          "2032839",
          "3005529799",
          "9612316",
          "2521625",
          "3005360469",
          "3002809144",
          "3005333358"
        ],
        "fei_number": [
          "3002806559",
          "2517506",
          "3007111389",
          "3012963943",
          "2432235",
          "3007019572",
          "2250051",
          "2020726",
          "3002642396",
          "1000136573",
          "3004185580",
          "3000308930",
          "3005670738",
          "2122870",
          "1219913",
          "3005529799",
          "2967",
          "3002808328",
          "2521625",
          "3002809144",
          "3005333358"
        ]
      },
      "zip_code": "19714",
      "applicant": "Siemens Healthcare Diagnostics, Inc.",
      "decision_date": "2011-04-06",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604",
      "advisory_committee": "IM",
      "contact": "PAMELA  JURGA",
      "expedited_review_flag": "",
      "k_number": "K100375",
      "state": "DE",
      "date_received": "2010-02-12",
      "review_advisory_committee": "IM",
      "postal_code": "19714",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}