{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "SAL",
      "openfda": {
        "k_number": [
          "DEN230034"
        ]
      },
      "review_panel": "HE",
      "medical_specialty": "HE",
      "device_name": "Device, Automated Cell Locating, Bone Marrow",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Hematology",
      "device_class": "2",
      "definition": "An automated cell-locating device for bone marrow aspirate is an in vitro diagnostic device intended for prescription use that automatically locates and presents images of hematopoietic cells on a bone marrow aspirate smear obtained from patients being evaluated for hematologic diseases. The device assists operators to identify and classify each cell according to type.",
      "regulation_number": "864.5261",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}