{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Bellevue",
      "advisory_committee_description": "Microbiology",
      "address_1": "Bartels Diagnostics Division",
      "address_2": "P.O. Box 3093",
      "statement_or_summary": "Summary",
      "product_code": "LGC",
      "openfda": {
        "registration_number": [
          "3006198300",
          "1641328",
          "9617136",
          "9610746",
          "1827821",
          "2432235",
          "3008344661",
          "2023365",
          "3005333358",
          "1318354",
          "3022178699",
          "2029372",
          "2090110",
          "3032705",
          "3007208259",
          "2242436",
          "1036362",
          "3002806944"
        ],
        "fei_number": [
          "3006198300",
          "1641328",
          "1000306617",
          "3002701146",
          "2432235",
          "1827821",
          "3008344661",
          "2023365",
          "3005333358",
          "1318354",
          "3022178699",
          "3007208259",
          "3002806557",
          "2242436",
          "1036362",
          "3002806944",
          "3002806511",
          "3002346973"
        ],
        "device_name": "Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3305",
        "device_class": "2"
      },
      "zip_code": "98009",
      "applicant": "Baxter Diagnostics, Inc.",
      "decision_date": "1992-12-15",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA",
      "advisory_committee": "MI",
      "contact": "MALLINAK",
      "expedited_review_flag": "",
      "k_number": "K922333",
      "state": "WA",
      "date_received": "1992-05-13",
      "review_advisory_committee": "MI",
      "postal_code": "98009",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}