{
  "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",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "SAC",
      "openfda": {
        "k_number": [
          "DEN230024"
        ],
        "registration_number": [
          "3003453957"
        ],
        "fei_number": [
          "3003453957"
        ]
      },
      "review_panel": "HE",
      "medical_specialty": "HE",
      "device_name": "Adamts13 Activity Test System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Hematology",
      "device_class": "2",
      "definition": "An ADAMTS13 activity test system is a qualitative or quantitative in vitro diagnostic device intended to detect ADAMTS13 activity in human blood specimens collected from patients being evaluated for thrombotic microangiopathy. This device is indicated to aid in the diagnosis and management of patients being evaluated for thrombotic thrombocytopenic purpura in conjunction with other clinical and laboratory findings.",
      "regulation_number": "864.7297",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}