{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Hennigsdorf",
      "advisory_committee_description": "Immunology",
      "address_1": "Neuendorfstrasse 25",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "QXS",
      "openfda": {
        "registration_number": [
          "3005847079",
          "3003561301",
          "2032839"
        ],
        "fei_number": [
          "3005847079",
          "3003561301",
          "3004185580"
        ],
        "device_name": "Chromogranin A",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6010",
        "device_class": "2"
      },
      "zip_code": "16761",
      "applicant": "B.R.A.H.M.S GmbH, Part of Thermo Fisher",
      "decision_date": "2023-09-18",
      "decision_code": "SESE",
      "country_code": "DE",
      "device_name": "B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC",
      "advisory_committee": "IM",
      "contact": "Anne  Kummerow",
      "expedited_review_flag": "",
      "k_number": "K222251",
      "state": "",
      "date_received": "2022-07-27",
      "review_advisory_committee": "IM",
      "postal_code": "16761",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}