{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Cleveland",
      "advisory_committee_description": "Hematology",
      "address_1": "13000 Shaker Blvd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NRF",
      "openfda": {
        "registration_number": [
          "3016090200",
          "3038206980",
          "3014053517",
          "3008987086",
          "1221433",
          "3003646592",
          "3043127699",
          "2025606",
          "3003750510",
          "3035387168",
          "1950302"
        ],
        "fei_number": [
          "3016090200",
          "3038206980",
          "3014053517",
          "3008987086",
          "1221433",
          "3003646592",
          "3043127699",
          "2025606",
          "3003750510",
          "3035387168",
          "1950302"
        ],
        "device_name": "Material, Quality Control, Semen Analysis",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.8625",
        "device_class": "2"
      },
      "zip_code": "44120",
      "applicant": "Fertility Solutions, Inc.",
      "decision_date": "2004-06-02",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED",
      "advisory_committee": "HE",
      "contact": "SUSAN A ROTHMANN, PH.D., HCLD",
      "expedited_review_flag": "",
      "k_number": "K041240",
      "state": "OH",
      "date_received": "2004-05-11",
      "review_advisory_committee": "HE",
      "postal_code": "44120",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}