{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Des Plaines",
      "advisory_committee_description": "Microbiology",
      "address_1": "1300 E Touhy Ave.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MKZ",
      "openfda": {
        "device_name": "Dna Probe, Nucleic Acid Amplification, Chlamydia",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3120",
        "device_class": "1",
        "registration_number": [
          "3002444944",
          "1119779",
          "3003795116",
          "3038610665",
          "3007420875",
          "3019837962",
          "2243471",
          "3017907743",
          "3016838963",
          "3004141078",
          "3025663244",
          "3009613136",
          "3013019728",
          "2024800",
          "9610126",
          "3005248192",
          "3012598266",
          "3026940910",
          "3006198300",
          "2436875",
          "3004530258",
          "3016608638"
        ],
        "fei_number": [
          "3002444944",
          "1119779",
          "3003795116",
          "1000521444",
          "3002806559",
          "3038610665",
          "3007420875",
          "3019837962",
          "2243471",
          "3017907743",
          "3016838963",
          "3004141078",
          "3025663244",
          "3009613136",
          "3013019728",
          "2024800",
          "3005248192",
          "3012598266",
          "3026940910",
          "3006198300",
          "3004530258",
          "3016608638"
        ]
      },
      "zip_code": "60018",
      "applicant": "Abbott Molecular, Inc.",
      "decision_date": "2008-07-10",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT",
      "advisory_committee": "MI",
      "contact": "PAULA E MARTIN",
      "expedited_review_flag": "",
      "k_number": "K080739",
      "state": "IL",
      "date_received": "2008-03-17",
      "review_advisory_committee": "MI",
      "postal_code": "60018",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}