{
  "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": "Rochester",
      "advisory_committee_description": "Clinical Toxicology",
      "address_1": "100 Indigo Creek Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "LEG",
      "openfda": {
        "registration_number": [
          "3006198300",
          "2432235",
          "9610529",
          "2517506",
          "3010825766",
          "3012963943",
          "3002809144",
          "2050012",
          "2050010",
          "3002642396",
          "2250051",
          "3000308930",
          "3005333358",
          "3004493545",
          "1319681",
          "9610126",
          "1036362",
          "3002806944",
          "3003795116",
          "3003871639",
          "1319808",
          "3010939897",
          "3003561301"
        ],
        "fei_number": [
          "3006198300",
          "2432235",
          "2517506",
          "3010825766",
          "3012963943",
          "3002809144",
          "2050012",
          "2050010",
          "3002642396",
          "2250051",
          "3000308930",
          "3005333358",
          "3004493545",
          "1000305841",
          "1036362",
          "3002806944",
          "3003795116",
          "3002806559",
          "3003871639",
          "3010939897",
          "3002806560",
          "3003561301",
          "1000136573"
        ],
        "device_name": "Enzyme Immunoassay, Valproic Acid",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3645",
        "device_class": "2"
      },
      "zip_code": "14626",
      "applicant": "Ortho-Clinical Diagnostics, Inc.",
      "decision_date": "2004-12-01",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS",
      "advisory_committee": "TX",
      "contact": "CAREY A MAYO",
      "expedited_review_flag": "",
      "k_number": "K042476",
      "state": "NY",
      "date_received": "2004-09-13",
      "review_advisory_committee": "CH",
      "postal_code": "14626",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}