{
  "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": "2026-05-25",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Guelph",
      "advisory_committee_description": "Obstetrics/Gynecology",
      "address_1": "24 Norwich St. E.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MQL",
      "openfda": {
        "registration_number": [
          "3018010054",
          "3012853704",
          "3014295858",
          "3003274090",
          "3003995932",
          "3003766921",
          "3005580113",
          "3015140190",
          "1216677",
          "3021166069",
          "3003272500",
          "1221433",
          "3010413864",
          "3033813683",
          "3004048494",
          "3004882774",
          "3007738736",
          "3007800906",
          "3036725842",
          "2031824",
          "3016126174",
          "2022379",
          "3030390242",
          "3017896194",
          "9616005",
          "3030681110",
          "1222779",
          "3025773437",
          "3008876063",
          "3014755376",
          "3036495174"
        ],
        "fei_number": [
          "3002757762",
          "3018010054",
          "3012853704",
          "3014295858",
          "3003274090",
          "3003995932",
          "3003766921",
          "3005580113",
          "3015140190",
          "1216677",
          "3021166069",
          "3003272500",
          "1221433",
          "3010413864",
          "3033813683",
          "3004048494",
          "1000120774",
          "3004882774",
          "3007738736",
          "3007800906",
          "3004848623",
          "3036725842",
          "3016126174",
          "2022379",
          "3030390242",
          "3017896194",
          "3030681110",
          "3025773437",
          "3008876063",
          "3014755376",
          "3036495174"
        ],
        "device_name": "Media, Reproductive",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.6180",
        "device_class": "2"
      },
      "zip_code": "N1H2G6",
      "applicant": "Casebioscience, Inc.",
      "decision_date": "2025-03-21",
      "decision_code": "SESE",
      "country_code": "CA",
      "device_name": "CaseMONO™ Culture  (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)",
      "advisory_committee": "OB",
      "contact": "Monica  Mezezi",
      "expedited_review_flag": "",
      "k_number": "K242107",
      "state": "",
      "date_received": "2024-07-18",
      "review_advisory_committee": "OB",
      "postal_code": "N1H2G6",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}