{
  "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": "2026-09-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Marburg",
      "advisory_committee_description": "Hematology",
      "address_1": "Emil-Von-Behring Strasse 76",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "DAP",
      "openfda": {
        "device_name": "Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7320",
        "device_class": "2",
        "registration_number": [
          "3006198300",
          "3002637618",
          "2517506",
          "9710666",
          "9615037",
          "3003985394",
          "2029372",
          "9610746",
          "3008386529",
          "2032900",
          "2245451",
          "8020790",
          "1219738",
          "3005174594",
          "3013660430",
          "2020726",
          "3013982035",
          "9610806",
          "1217183",
          "3003691680",
          "2084025",
          "3005360469",
          "1181121",
          "2246703",
          "3003750284",
          "3003030793",
          "3037000637",
          "9610126"
        ],
        "fei_number": [
          "3006198300",
          "3005670738",
          "3002637618",
          "2517506",
          "3004445302",
          "3003985394",
          "3008386529",
          "2245451",
          "1219738",
          "3002806557",
          "1000306617",
          "3005174594",
          "3013660430",
          "2020726",
          "3013982035",
          "1217183",
          "3003261083",
          "3003565434",
          "3003691680",
          "3002806559",
          "1000611339",
          "2084025",
          "1181121",
          "2246703",
          "3003750284",
          "3003030793",
          "3037000637",
          "3001644026"
        ]
      },
      "zip_code": "35041",
      "applicant": "Siemens Healthcare Diagnostic Products GmbH",
      "decision_date": "2026-08-11",
      "decision_code": "SESE",
      "country_code": "DE",
      "device_name": "INNOVANCE® D-Dimer 2.0 (SMN 10873803)",
      "advisory_committee": "HE",
      "contact": "Petra Maria  Dissmann",
      "expedited_review_flag": "",
      "k_number": "K253985",
      "state": "",
      "date_received": "2025-12-12",
      "review_advisory_committee": "HE",
      "postal_code": "35041",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}