{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Raritan",
      "advisory_committee_description": "Immunology",
      "address_1": "P.O.Box 38",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "LKO",
      "openfda": {
        "device_name": "Anti-Rnp Antibody, Antigen And Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5100",
        "device_class": "2",
        "registration_number": [
          "9610566",
          "3039353646",
          "3003268355",
          "8043792",
          "3007118747",
          "2026994",
          "3003935253",
          "2915274",
          "3007361513",
          "3004973408",
          "3012348571",
          "1421346",
          "9680745"
        ],
        "fei_number": [
          "3039353646",
          "3003268355",
          "3005774014",
          "3002808269",
          "3007118747",
          "3003935253",
          "2026994",
          "2915274",
          "3007361513",
          "3004973408",
          "3012348571",
          "3002807876",
          "1421346"
        ]
      },
      "zip_code": "08869",
      "applicant": "Zeus Scientific, Inc.",
      "decision_date": "1998-11-18",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE",
      "advisory_committee": "IM",
      "contact": "MARK J KOPNITSKY",
      "expedited_review_flag": "",
      "k_number": "K983465",
      "state": "NJ",
      "date_received": "1998-10-01",
      "review_advisory_committee": "IM",
      "postal_code": "08869",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}