{
  "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",
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      "third_party_flag": "N",
      "city": "Charlottesville",
      "advisory_committee_description": "Hematology",
      "address_1": "400 Preston Ave.",
      "address_2": "Suite 250",
      "statement_or_summary": "Summary",
      "product_code": "QFR",
      "openfda": {
        "device_name": "Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties",
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      "device_name": "Quantra QPlus System",
      "advisory_committee": "HE",
      "contact": "Anne  Zavertnik",
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      "k_number": "K201513",
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      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
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