{
  "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,
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Sunnyvale",
      "advisory_committee_description": "Clinical Toxicology",
      "address_1": "1190 Bordeaux Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "OTF",
      "openfda": {
        "registration_number": [
          "3005755244",
          "3005360469"
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        "fei_number": [
          "3005755244",
          "3005670738"
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        "device_name": "Gabapentin Assay",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3350",
        "device_class": "2"
      },
      "zip_code": "94089",
      "applicant": "Ark Diagnostics, Inc.",
      "decision_date": "2010-11-23",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0",
      "advisory_committee": "TX",
      "contact": "JOHNNY  VALDEZ",
      "expedited_review_flag": "",
      "k_number": "K101574",
      "state": "CA",
      "date_received": "2010-06-07",
      "review_advisory_committee": "TX",
      "postal_code": "94089",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}