{
  "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": 2
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Toronto",
      "advisory_committee_description": "Medical Genetics",
      "address_1": "96 Colbeck St.",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "QNC",
      "openfda": {
        "device_name": "Whole Exome Sequencing Constituent Device",
        "medical_specialty_description": "Medical Genetics",
        "regulation_number": "866.6000",
        "device_class": "2"
      },
      "zip_code": "M6S1 V2",
      "applicant": "Helix Opco, LLC",
      "decision_date": "2020-12-23",
      "decision_code": "DENG",
      "country_code": "CA",
      "device_name": "Helix Laboratory Platform",
      "advisory_committee": "MG",
      "contact": "Gloria  Lee",
      "expedited_review_flag": "",
      "k_number": "DEN190035",
      "state": "",
      "date_received": "2019-08-02",
      "review_advisory_committee": "MG",
      "postal_code": "M6S1 V2",
      "decision_description": "Unknown",
      "clearance_type": "Direct"
    }
  ]
}