{
  "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": "Indianapolis",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "9115 Hague Rd.",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "CGS",
      "openfda": {
        "registration_number": [
          "8020316",
          "3006198300",
          "1000403749",
          "8040374",
          "2432235",
          "3016438761",
          "2517506",
          "9680746",
          "1181121",
          "3010825766",
          "3005146313",
          "1827821",
          "3003593973",
          "1220972",
          "2050012",
          "3000148879",
          "2050010",
          "2030861",
          "2247288",
          "3005333358",
          "1616487",
          "3004493545",
          "8023024",
          "3013660430",
          "1832216",
          "2085064"
        ],
        "fei_number": [
          "3006198300",
          "1000403749",
          "3000215862",
          "2432235",
          "3016438761",
          "2517506",
          "1181121",
          "3010825766",
          "5864",
          "3005146313",
          "1827821",
          "1000135102",
          "3003593973",
          "1220972",
          "2050012",
          "3002806809",
          "3000148879",
          "2050010",
          "3005333358",
          "1616487",
          "6387",
          "3004493545",
          "3013660430",
          "1000122044",
          "1832216",
          "1000206808"
        ],
        "device_name": "Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      },
      "zip_code": "46250",
      "applicant": "Boehringer Mannheim Corp.",
      "decision_date": "1990-09-27",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "REFLOTRON CREATINE KINASE TEST TABS",
      "advisory_committee": "CH",
      "contact": "JOHN D STEVENS",
      "expedited_review_flag": "",
      "k_number": "K904102",
      "state": "IN",
      "date_received": "1990-09-06",
      "review_advisory_committee": "CH",
      "postal_code": "46250",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}