{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Chaska",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "1000 Lake Hazeltine Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MRG",
      "openfda": {
        "registration_number": [
          "3003268355",
          "1222302",
          "2915274",
          "2432235",
          "3005529799",
          "3009092698",
          "3009335633",
          "3007111389",
          "2517506",
          "9680746",
          "3032705",
          "3021841051",
          "2032839",
          "2182595",
          "9612316",
          "2122870",
          "8031673",
          "3010610113",
          "3005360469",
          "2245285",
          "3022178699",
          "2029372",
          "3007349751",
          "2244821",
          "3002809144",
          "3012963943",
          "3007118747",
          "2032682",
          "3002637618",
          "2032900",
          "3014862385",
          "3007361513",
          "3002642396",
          "8021924",
          "3005333358",
          "3000308930",
          "2250051",
          "1319681",
          "9610126",
          "3005094123",
          "3010324880",
          "3002800697",
          "3009518015",
          "2020726",
          "1219913",
          "3011989923",
          "8023018",
          "3005174594",
          "1063851",
          "2032087",
          "9615777"
        ],
        "fei_number": [
          "3003268355",
          "2915274",
          "2432235",
          "3005529799",
          "3009092698",
          "3009335633",
          "3007111389",
          "2517506",
          "3004445302",
          "3021841051",
          "2182595",
          "2122870",
          "3010610113",
          "1000121039",
          "3002701146",
          "2967",
          "2245285",
          "3022178699",
          "3007349751",
          "3007034602",
          "2244821",
          "3002809144",
          "3012963943",
          "3007118747",
          "3002637618",
          "3014862385",
          "1000442352",
          "1000306617",
          "3003952975",
          "3007361513",
          "3002642396",
          "3000308930",
          "3005333358",
          "2250051",
          "3002807272",
          "3005094123",
          "3010324880",
          "3003355251",
          "3002800697",
          "3009518015",
          "3002806559",
          "2020726",
          "1219913",
          "3002808328",
          "3011989923",
          "3002485711",
          "3005670738",
          "3005174594",
          "3004185580",
          "1000206808",
          "1000136573"
        ],
        "device_name": "System, Test, Vitamin D",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1825",
        "device_class": "2"
      },
      "zip_code": "55318",
      "applicant": "Beckman Coulter, Inc.",
      "decision_date": "2014-12-22",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Access 25(OH) Vitamin  D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst",
      "advisory_committee": "CH",
      "contact": "Ryan  Severson",
      "expedited_review_flag": "",
      "k_number": "K142373",
      "state": "MN",
      "date_received": "2014-08-25",
      "review_advisory_committee": "CH",
      "postal_code": "55318",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}