{
  "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": "2026-07-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "OYG",
      "openfda": {
        "registration_number": [
          "3002800697"
        ],
        "fei_number": [
          "3002800697"
        ],
        "k_number": [
          "K111452"
        ]
      },
      "review_panel": "CH",
      "medical_specialty": "CH",
      "device_name": "St2 Assay",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Chemistry",
      "device_class": "2",
      "definition": "Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.",
      "regulation_number": "862.1117",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}