{
  "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": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Miami",
      "advisory_committee_description": "Hematology",
      "address_1": "11800 SW 147th Ave.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "OYE",
      "openfda": {
        "registration_number": [
          "3016954941",
          "3027394506",
          "1061932",
          "3003589956",
          "8043379",
          "1017835",
          "1064130",
          "3008494306",
          "3003244710",
          "3008352382",
          "8023018"
        ],
        "fei_number": [
          "3016954941",
          "3027394506",
          "3002807272",
          "3003589956",
          "1017835",
          "3008494306",
          "3000203293",
          "3003244710",
          "3008352382",
          "3003413192",
          "3002684533"
        ],
        "device_name": "Flow Cytometric Reagents And Accessories.",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5220",
        "device_class": "2"
      },
      "zip_code": "33196",
      "applicant": "Beckman Coulter, Inc.",
      "decision_date": "2015-04-10",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS",
      "advisory_committee": "HE",
      "contact": "ANTHONY  DENNIS",
      "expedited_review_flag": "",
      "k_number": "K141932",
      "state": "FL",
      "date_received": "2014-07-16",
      "review_advisory_committee": "IM",
      "postal_code": "33196",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}