{
  "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": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Brisbane",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "3260 Bayshore Blvd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "OJQ",
      "openfda": {
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        "device_name": "Cardiac Allograft Gene Expression Profiling Test System",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "862.1163",
        "device_class": "2"
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      "zip_code": "94005",
      "applicant": "Caredx, Inc.",
      "decision_date": "2023-09-13",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "AlloMap Heart Molecular Expression Testing",
      "advisory_committee": "CV",
      "contact": "Camilla  Lu",
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      "k_number": "K221640",
      "state": "CA",
      "date_received": "2022-06-06",
      "review_advisory_committee": "CH",
      "postal_code": "94005",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}