{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Sterling Heights",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "34210 Dequindre Rd.",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "CGS",
      "openfda": {
        "registration_number": [
          "8040374",
          "8020316",
          "2030861",
          "2517506",
          "3016438761",
          "1000403749",
          "3005333358",
          "3006198300",
          "3013660430",
          "3004493545",
          "9680746",
          "2085064",
          "1616487",
          "3010825766",
          "1220972",
          "3000148879",
          "3003593973",
          "1181121",
          "1832216",
          "1827821",
          "8023024",
          "2247288",
          "2050012",
          "2050010",
          "2432235"
        ],
        "fei_number": [
          "2517506",
          "3016438761",
          "1000403749",
          "3005333358",
          "3006198300",
          "5864",
          "3013660430",
          "3004493545",
          "1616487",
          "1000135102",
          "3010825766",
          "1220972",
          "3000148879",
          "3003593973",
          "1181121",
          "1832216",
          "1000122044",
          "1827821",
          "3000215862",
          "1000206808",
          "2050012",
          "3002806809",
          "2050010",
          "6387",
          "2432235"
        ],
        "device_name": "Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      },
      "zip_code": "48077",
      "applicant": "Sterling Diagnostics, Inc.",
      "decision_date": "1986-02-11",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "CPK REAGENT SET (COLORIMETRIC)",
      "advisory_committee": "CH",
      "contact": "DAVID L CALLENDER",
      "expedited_review_flag": "",
      "k_number": "K860096",
      "state": "MI",
      "date_received": "1986-01-10",
      "review_advisory_committee": "CH",
      "postal_code": "48077",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}