{
  "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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      "third_party_flag": "N",
      "city": "Pleasanton",
      "advisory_committee_description": "Microbiology",
      "address_1": "4300 Hacienda Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "QMI",
      "openfda": {
        "device_name": "Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna",
        "medical_specialty_description": "Microbiology",
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      "applicant": "Roche Molecular Systems, Inc.",
      "decision_date": "2020-09-02",
      "decision_code": "SESE",
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      "device_name": "cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit",
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      "k_number": "K202215",
      "state": "CA",
      "date_received": "2020-08-06",
      "review_advisory_committee": "MI",
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      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}