{
  "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": "Edgbaston",
      "advisory_committee_description": "Immunology",
      "address_1": "8 Caltrope Rd.",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "OPX",
      "openfda": {
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          "9614373"
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          "3012471076",
          "3002808340"
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        "device_name": "Immunoglobulin A Kappa Heavy & Light Chain Combined",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5510",
        "device_class": "2"
      },
      "zip_code": "B15 1QT",
      "applicant": "The Binding Site Group , Ltd.",
      "decision_date": "2015-11-06",
      "decision_code": "SESE",
      "country_code": "GB",
      "device_name": "Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS",
      "advisory_committee": "IM",
      "contact": "STEPHANIE  THOULESS",
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      "k_number": "K151759",
      "state": "",
      "date_received": "2015-06-29",
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      "postal_code": "B15 1QT",
      "decision_description": "Substantially Equivalent",
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}