{
  "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": "San Jose",
      "advisory_committee_description": "Hematology",
      "address_1": "2350 Qume Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PMG",
      "openfda": {
        "device_name": "Automated Multicolor Fluorescent Imaging Cytometric Analysis System",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5220",
        "device_class": "2",
        "registration_number": [
          "3027394506",
          "3008352382"
        ],
        "fei_number": [
          "3027394506",
          "3008352382"
        ]
      },
      "zip_code": "95131",
      "applicant": "Becton, Dickinson and Company",
      "decision_date": "2015-12-17",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit",
      "advisory_committee": "HE",
      "contact": "Catherine(Katie)  Bessette",
      "expedited_review_flag": "",
      "k_number": "K150815",
      "state": "CA",
      "date_received": "2015-03-27",
      "review_advisory_committee": "IM",
      "postal_code": "95131",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}