{
  "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": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Beaumont",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "1530 Lindbergh Dr.",
      "address_2": "P.O. Box 752",
      "statement_or_summary": "Statement",
      "product_code": "CFE",
      "openfda": {
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        "medical_specialty_description": "Clinical Chemistry",
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          "1618982",
          "6387"
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      "applicant": "Helena Laboratories",
      "decision_date": "2002-03-29",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452",
      "advisory_committee": "CH",
      "contact": "PATRICIA  FRANKS",
      "expedited_review_flag": "",
      "k_number": "K020467",
      "state": "TX",
      "date_received": "2002-02-12",
      "review_advisory_committee": "CH",
      "postal_code": "77704",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}