{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "PPU",
      "openfda": {
        "k_number": [
          "DEN150059",
          "K183648",
          "K251511"
        ],
        "registration_number": [
          "3023339158",
          "3011637800",
          "3009288740"
        ],
        "fei_number": [
          "3023339158",
          "3011637800",
          "3009288740"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Microbial Colony Image Assessment System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "A microbial colony image assessment system is an instrument that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic characteristics. This device type provides a semi-quantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All urine culture plates that are identified as positive for growth by the APAS Compact, when using its urine analysis module, must be reviewed by a trained microbiologist.",
      "regulation_number": "866.2190",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}