{
  "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": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "San Jose",
      "advisory_committee_description": "Clinical Toxicology",
      "address_1": "3403 Yerba Buena Rd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "DML",
      "openfda": {
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          "9610126",
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          "2432235"
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        "device_name": "Nad-Nadh, Specific Reagent For Alcohol Enzyme Method",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3040",
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      "applicant": "Syva Co.",
      "decision_date": "2000-02-01",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL",
      "advisory_committee": "TX",
      "contact": "PAUL L ROGERS",
      "expedited_review_flag": "",
      "k_number": "K993980",
      "state": "CA",
      "date_received": "1999-11-24",
      "review_advisory_committee": "TX",
      "postal_code": "95161",
      "decision_description": "Substantially Equivalent",
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}