{
  "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": "Newark",
      "advisory_committee_description": "Immunology",
      "address_1": "P.O. Box 6101",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "DBA",
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        "regulation_number": "866.5250",
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      "applicant": "Dade Behring, Inc.",
      "decision_date": "2007-12-21",
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      "device_name": "DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON",
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      "contact": "KATHLEEN  DRAY-LYONS",
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      "k_number": "K072965",
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      "decision_description": "Substantially Equivalent",
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