{
  "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",
    "results": {
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      "third_party_flag": "N",
      "city": "Newark",
      "advisory_committee_description": "Clinical Toxicology",
      "address_1": "P.O. Box 6101 Bldg. 500;M.S.514",
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      "statement_or_summary": "Summary",
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        "medical_specialty_description": "Clinical Toxicology",
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      "applicant": "Dade Behring, Inc.",
      "decision_date": "2006-07-28",
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      "device_name": "DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE",
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      "contact": "LORRAINE H PIESTRAK",
      "expedited_review_flag": "",
      "k_number": "K062024",
      "state": "DE",
      "date_received": "2006-07-18",
      "review_advisory_committee": "TX",
      "postal_code": "19714",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
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}