{
  "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": "2026-07-27",
    "results": {
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      "third_party_flag": "N",
      "city": "San Diego",
      "advisory_committee_description": "Hematology",
      "address_1": "3595 John Hopkins Ct.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PHJ",
      "openfda": {
        "device_name": "System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations",
        "medical_specialty_description": "Hematology",
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        "device_class": "2"
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      "applicant": "Sequenom, Inc.",
      "decision_date": "2014-06-13",
      "decision_code": "SESE",
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      "device_name": "IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST",
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      "contact": "Robin  Weiner",
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      "k_number": "K132978",
      "state": "CA",
      "date_received": "2013-09-23",
      "review_advisory_committee": "PA",
      "postal_code": "92121",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}