{
  "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": "2026-10-19",
    "results": {
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  "results": [
    {
      "pma_number": "P210001",
      "supplement_number": "S009",
      "applicant": "Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)",
      "street_1": "1910 E. Innovation Park Dr.",
      "street_2": "",
      "city": "Tucson",
      "state": "AZ",
      "zip": "85755",
      "zip_ext": "",
      "generic_name": "Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay",
      "trade_name": "VENTANA MMR RxDx Panel Solid Tumors with dMMR status)",
      "product_code": "QNH",
      "advisory_committee": "PA",
      "advisory_committee_description": "Pathology",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2023-08-01",
      "decision_date": "2023-08-29",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "Addition of two contract manufacturers as approved suppliers of parts/components.",
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          "2028492",
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          "1000125183",
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        "device_name": "Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.1860",
        "device_class": "3"
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