{
  "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": "2026-09-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 45
    }
  },
  "results": [
    {
      "pma_number": "P160045",
      "supplement_number": "S005",
      "applicant": "Life Technologies Corporation",
      "street_1": "5781 Van Allen Way",
      "street_2": "",
      "city": "Carlsbad",
      "state": "CA",
      "zip": "92008",
      "zip_ext": "",
      "generic_name": "Next generation sequencing oncology panel, somatic or germline variant detection system",
      "trade_name": "Oncomine Dx Target",
      "product_code": "PQP",
      "advisory_committee": "PA",
      "advisory_committee_description": "Pathology",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2018-03-22",
      "decision_date": "2018-09-06",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for final updated labeling for the software change from Torrent Suite Dx version 5.6.4 to version 5.8.",
      "openfda": {
        "registration_number": [
          "3017020141",
          "3013200421",
          "3003335080",
          "3010679023",
          "3010889807",
          "3031598391",
          "3012090384",
          "3030654068",
          "3011104381",
          "3003218906",
          "3020703032",
          "3007287152"
        ],
        "fei_number": [
          "3013200421",
          "3003335080",
          "3010679023",
          "3010889807",
          "3016560486",
          "3031598391",
          "3012090384",
          "3030654068",
          "3008335090",
          "3011104381",
          "3003218906",
          "3007287152"
        ],
        "device_name": "Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}