{
  "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": "Brea",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "1075 W. Lambert Rd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "LBS",
      "openfda": {
        "registration_number": [
          "1181055",
          "3011989923",
          "9610529",
          "3007662974",
          "3003795116",
          "2247288",
          "1319809",
          "3004493545",
          "2517506",
          "3017379203",
          "3003539867",
          "3023197868",
          "8040374",
          "2032900",
          "1423455",
          "3021841051",
          "3012963943",
          "1616487",
          "3004192065",
          "3016438761",
          "3003593973",
          "2432235",
          "2050010",
          "1319681",
          "1319808",
          "3020978007",
          "2250051",
          "3002642396",
          "3015189693",
          "2027969",
          "3000308930",
          "3005452690",
          "1827821",
          "9610126",
          "2050012",
          "3006716639",
          "1220972",
          "2939693",
          "8020316",
          "1063851",
          "2030861",
          "3006198300",
          "3005333358",
          "9680746",
          "2085064"
        ],
        "fei_number": [
          "1181055",
          "3011989923",
          "3007662974",
          "3003795116",
          "3002806559",
          "3004493545",
          "2517506",
          "3017379203",
          "3023197868",
          "3000215862",
          "3021841051",
          "3004445302",
          "3012963943",
          "1000305841",
          "3004192065",
          "3016438761",
          "3003593973",
          "1616487",
          "2432235",
          "3006769061",
          "2050010",
          "3002806560",
          "1000442352",
          "1000125596",
          "3020978007",
          "2250051",
          "1000122044",
          "3000206414",
          "3002642396",
          "5864",
          "1000136573",
          "3015189693",
          "3000308930",
          "3005452690",
          "1827821",
          "1000305840",
          "3002806809",
          "1000206808",
          "1000135102",
          "2050012",
          "3006716639",
          "1220972",
          "2939693",
          "3006198300",
          "3005333358"
        ],
        "device_name": "Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1475",
        "device_class": "1"
      },
      "zip_code": "92821",
      "applicant": "Clinical Data, Inc.",
      "decision_date": "2007-12-20",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)",
      "advisory_committee": "CH",
      "contact": "WYNN  STOCKING",
      "expedited_review_flag": "",
      "k_number": "K071706",
      "state": "CA",
      "date_received": "2007-06-21",
      "review_advisory_committee": "CH",
      "postal_code": "92821",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}