{
  "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,
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Redmond",
      "advisory_committee_description": "Clinical Toxicology",
      "address_1": "6565 185th Ave., NE",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NVI",
      "openfda": {
        "device_name": "Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3100",
        "device_class": "2",
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          "2915274"
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        "fei_number": [
          "2915274"
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      "zip_code": "98052",
      "applicant": "Bio-Rad Laboratories, Inc.",
      "decision_date": "2005-10-27",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM",
      "advisory_committee": "TX",
      "contact": "CHRISTOPHER  BENTSEN",
      "expedited_review_flag": "",
      "k_number": "K043341",
      "state": "WA",
      "date_received": "2004-12-03",
      "review_advisory_committee": "IM",
      "postal_code": "98052",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}