{
  "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": 17
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Bothell",
      "advisory_committee_description": "Microbiology",
      "address_1": "21720 23rd Dr. SE Suite 150",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PGI",
      "openfda": {
        "registration_number": [
          "1524213",
          "3019837962",
          "2023365",
          "2024674",
          "1528450",
          "3005360469",
          "3005248192",
          "3011461582",
          "3010749841",
          "3003540236",
          "2032839"
        ],
        "fei_number": [
          "1524213",
          "3019837962",
          "1000122536",
          "3004185580",
          "2023365",
          "2024674",
          "3005670738",
          "3005248192",
          "3011461582",
          "3010749841",
          "3003540236"
        ],
        "device_name": "Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3309",
        "device_class": "2"
      },
      "zip_code": "98021",
      "applicant": "Elitechgroup",
      "decision_date": "2018-10-29",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "HSV 1 & 2 ELITe MGB Kit; ELITe InGenius",
      "advisory_committee": "MI",
      "contact": "Terry  Trimingham",
      "expedited_review_flag": "",
      "k_number": "K180559",
      "state": "WA",
      "date_received": "2018-03-01",
      "review_advisory_committee": "MI",
      "postal_code": "98021",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}