{
  "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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  "results": [
    {
      "third_party_flag": "N",
      "city": "Sacramento",
      "advisory_committee_description": "Immunology",
      "address_1": "9825 Goethe Rd., Suite #350",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "KTL",
      "openfda": {
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          "2915274",
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        "regulation_number": "866.5100",
        "device_class": "2"
      },
      "zip_code": "95827",
      "applicant": "Immuno Concepts, N.A. , Ltd.",
      "decision_date": "2023-05-26",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System",
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      "k_number": "K203599",
      "state": "CA",
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      "decision_description": "Substantially Equivalent",
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}