{
  "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,
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    }
  },
  "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": "OYE",
      "openfda": {
        "registration_number": [
          "3016954941",
          "3027394506",
          "1061932",
          "3003589956",
          "8043379",
          "1017835",
          "1064130",
          "3008494306",
          "3003244710",
          "3008352382",
          "8023018"
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        "fei_number": [
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          "3002807272",
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          "3008494306",
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          "3008352382",
          "3003413192",
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        "device_name": "Flow Cytometric Reagents And Accessories.",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5220",
        "device_class": "2"
      },
      "zip_code": "95131",
      "applicant": "Becton, Dickinson and Company",
      "decision_date": "2020-09-28",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit",
      "advisory_committee": "HE",
      "contact": "Niya  Su",
      "expedited_review_flag": "",
      "k_number": "K201814",
      "state": "CA",
      "date_received": "2020-07-01",
      "review_advisory_committee": "IM",
      "postal_code": "95131",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}