{
  "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 Calthorpe Rd.",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "PCN",
      "openfda": {
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          "9614373"
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          "3002808340"
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        "device_name": "Immunoglobulin G Kappa Heavy And Light Chain Combined",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5510",
        "device_class": "2"
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      "zip_code": "B15 1QT",
      "applicant": "The Binding Site Group , Ltd.",
      "decision_date": "2016-10-04",
      "decision_code": "SESE",
      "country_code": "GB",
      "device_name": "Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS",
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      "contact": "ANDREA  THOMAS",
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      "k_number": "K161854",
      "state": "",
      "date_received": "2016-07-06",
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      "postal_code": "B15 1QT",
      "decision_description": "Substantially Equivalent",
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}