{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Cypress",
      "advisory_committee_description": "Microbiology",
      "address_1": "11331 Valley View St.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "QOF",
      "openfda": {
        "registration_number": [
          "",
          "3019837962",
          "3011104381",
          "3011240982",
          "3004013603",
          "3009613136",
          "3004141078",
          "2243471",
          "3008632402",
          "2024800",
          "3010770794",
          "3004530258",
          "3016838963",
          "3005248192",
          "3009302820",
          "3003795116",
          "3002773840",
          "2023365",
          "3014654360",
          "3014553740",
          "3035381641",
          "3009976420",
          "3006028115",
          "3006247421",
          "1119779",
          "3014515702",
          "3011057574",
          "3007420875",
          "3002777243",
          "3021140368",
          "1528450"
        ],
        "fei_number": [
          "",
          "3019837962",
          "1000122536",
          "3011104381",
          "3011240982",
          "3004013603",
          "3009613136",
          "3004141078",
          "2243471",
          "3008632402",
          "2024800",
          "3010770794",
          "3004530258",
          "3016838963",
          "3005248192",
          "3009302820",
          "3003795116",
          "3002773840",
          "2023365",
          "3014654360",
          "3014553740",
          "3035381641",
          "3009976420",
          "3006028115",
          "3006247421",
          "1119779",
          "3014515702",
          "3011057574",
          "3007420875",
          "3002777243",
          "3021140368"
        ],
        "device_name": "Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3981",
        "device_class": "2"
      },
      "zip_code": "90630",
      "applicant": "Diasorin Molecular, LLC",
      "decision_date": "2025-10-30",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)",
      "advisory_committee": "MI",
      "contact": "Michael  Treas",
      "expedited_review_flag": "",
      "k_number": "K252387",
      "state": "CA",
      "date_received": "2025-07-31",
      "review_advisory_committee": "MI",
      "postal_code": "90630",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}