{
  "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": "Rochester",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "100 Indigo Creek Dr.",
      "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": "14626",
      "applicant": "Ortho-Clinical Diagnostics, Inc.",
      "decision_date": "2004-10-28",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE",
      "advisory_committee": "CH",
      "contact": "Darlene J Phillips",
      "expedited_review_flag": "",
      "k_number": "K042006",
      "state": "NY",
      "date_received": "2004-07-26",
      "review_advisory_committee": "CH",
      "postal_code": "14626",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}