{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Tarrytown",
      "advisory_committee_description": "Clinical Toxicology",
      "address_1": "511 Benedict Ave.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "LEG",
      "openfda": {
        "registration_number": [
          "9610529",
          "3003795116",
          "3010939897",
          "1036362",
          "3004493545",
          "2517506",
          "3012963943",
          "2432235",
          "3003871639",
          "2050010",
          "1319681",
          "1319808",
          "2250051",
          "3002642396",
          "3003561301",
          "3000308930",
          "9610126",
          "2050012",
          "3010825766",
          "3006198300",
          "3002809144",
          "3005333358",
          "3002806944"
        ],
        "fei_number": [
          "3003795116",
          "3010939897",
          "3002806559",
          "1036362",
          "3004493545",
          "2517506",
          "3012963943",
          "1000305841",
          "2432235",
          "3003871639",
          "2050010",
          "3002806560",
          "2250051",
          "3002642396",
          "3003561301",
          "1000136573",
          "3000308930",
          "2050012",
          "3010825766",
          "3006198300",
          "3002809144",
          "3005333358",
          "3002806944"
        ],
        "device_name": "Enzyme Immunoassay, Valproic Acid",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3645",
        "device_class": "2"
      },
      "zip_code": "10591",
      "applicant": "Bayer Healthcare, LLC",
      "decision_date": "2005-02-08",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ADVIA IMS VALPROIC ACID METHOD",
      "advisory_committee": "TX",
      "contact": "ANDRES  HOLLE",
      "expedited_review_flag": "",
      "k_number": "K042807",
      "state": "NY",
      "date_received": "2004-10-12",
      "review_advisory_committee": "CH",
      "postal_code": "10591",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}