{
  "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": "Sparks",
      "advisory_committee_description": "Microbiology",
      "address_1": "7loveton Cir.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PCI",
      "openfda": {
        "device_name": "Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3990",
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          "1119779",
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          "1119779",
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      "applicant": "Becton, Dickinson and Company",
      "decision_date": "2025-10-31",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System",
      "advisory_committee": "MI",
      "contact": "Joseph  Basore",
      "expedited_review_flag": "",
      "k_number": "K250358",
      "state": "MD",
      "date_received": "2025-02-07",
      "review_advisory_committee": "MI",
      "postal_code": "21152",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}