{
  "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": "2026-07-27",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Cambridge",
      "advisory_committee_description": "Medical Genetics",
      "address_1": "3-4 Technopark, Newmarket Rd.",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "QDI",
      "openfda": {
        "registration_number": [
          "9710378",
          "3011279282"
        ],
        "fei_number": [
          "3011279282",
          "3002646096"
        ],
        "device_name": "Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies",
        "medical_specialty_description": "Medical Genetics",
        "regulation_number": "864.1880",
        "device_class": "2"
      },
      "zip_code": "CB5 8PB",
      "applicant": "Cytocell, Ltd.",
      "decision_date": "2018-12-21",
      "decision_code": "DENG",
      "country_code": "GB",
      "device_name": "MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit",
      "advisory_committee": "MG",
      "contact": "Xavier  Baker",
      "expedited_review_flag": "",
      "k_number": "DEN170070",
      "state": "",
      "date_received": "2017-09-29",
      "review_advisory_committee": "MG",
      "postal_code": "CB5 8PB",
      "decision_description": "Unknown",
      "clearance_type": "Direct"
    }
  ]
}