{
  "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": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Oakwood Village",
      "advisory_committee_description": "Microbiology",
      "address_1": "One Thermo Fisher Way",
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      "statement_or_summary": "Statement",
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      "applicant": "Thermo Fisher Scientific",
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      "device_name": "Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL",
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      "decision_description": "Substantially Equivalent",
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