{
  "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": "2026-09-14",
    "results": {
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  "results": [
    {
      "pma_number": "P130017",
      "supplement_number": "",
      "applicant": "Exact Sciences Corporation",
      "street_1": "441 Charmany Dr.",
      "street_2": "",
      "city": "Medison",
      "state": "WI",
      "zip": "53719",
      "zip_ext": "",
      "generic_name": "System, colorectal neoplasia, DNA methylation and hemoglobin detection",
      "trade_name": "COLOGUARD",
      "product_code": "PHP",
      "advisory_committee": "PA",
      "advisory_committee_description": "Pathology",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2013-06-07",
      "decision_date": "2014-08-11",
      "docket_number": "14M-1193",
      "fed_reg_notice_date": "2014-08-13",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE COLOGUARD.  COLOGUARD IS INTENDED FOR THE QUALITATIVE DETECTION OF COLORECTAL NEOPLASIA ASSOCIATED DNA MARKERS AND FOR THE PRESENCE OF OCCULT HEMOGLOBIN IN HUMAN STOOL. A POSITIVE RESULT MAY INDICATE THE PRESENCE OF COLORECTAL CANCER (CRC) OR ADVANCED ADENOMA (AA) AND SHOULD BE FOLLOWED BY DIAGNOSTIC COLONOSCOPY. COLOGUARD IS INDICATED TO SCREEN ADULTS OF EITHER SEX, 50 YEARS OR OLDER, WHO ARE AT TYPICAL AVERAGE-RISK FOR CRC. COLOGUARD IS NOT A REPLACEMENT FOR DIAGNOSTIC COLONOSCOPY OR SURVEILLANCE COLONOSCOPY IN HIGH RISK INDIVIDUALS.",
      "openfda": {
        "device_name": "System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
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