{
  "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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    }
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  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "SHB",
      "openfda": {
        "k_number": [
          "K251281"
        ]
      },
      "review_panel": "CH",
      "medical_specialty": "CH",
      "device_name": "Creatinine Test System For At Home Prescription Use",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Chemistry",
      "device_class": "2",
      "definition": "For the quantitative measurement of creatinine in home use settings by patients as an aid to monitor kidney function. This device is for prescription use only.",
      "regulation_number": "862.1225",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
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}