{
  "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,
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Carlsbad",
      "advisory_committee_description": "Clinical Toxicology",
      "address_1": "5964 La Pl. Ct.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "ODW",
      "openfda": {
        "device_name": "Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3360",
        "device_class": "2",
        "registration_number": [
          "3005406097"
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        "fei_number": [
          "3005406097"
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      "zip_code": "92008",
      "applicant": "Genmark Diagnostics, Incorporated",
      "decision_date": "2016-05-26",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "eSensor Warfarin Sensitivity Saliva Test",
      "advisory_committee": "TX",
      "contact": "ALAN  MADERAZO",
      "expedited_review_flag": "",
      "k_number": "K152612",
      "state": "CA",
      "date_received": "2015-09-14",
      "review_advisory_committee": "CH",
      "postal_code": "92008",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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  ]
}