{
  "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": "Lincolnshire",
      "advisory_committee_description": "Hematology",
      "address_1": "300 Knightsbridge Pkwy., #150",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "LCP",
      "openfda": {
        "device_name": "Assay, Glycosylated Hemoglobin",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7470",
        "device_class": "2",
        "registration_number": [
          "2084025",
          "9610529",
          "3017548799",
          "3003795116",
          "3007662974",
          "3012526002",
          "3004529019",
          "3004493545",
          "2517506",
          "3043149833",
          "1219029",
          "3003539867",
          "1423455",
          "3023162659",
          "2032900",
          "3003422726",
          "8043889",
          "1616487",
          "8031673",
          "3016438761",
          "2432235",
          "3014607865",
          "3043654757",
          "2050010",
          "2915274",
          "9610633",
          "3004111573",
          "1717966",
          "1832816",
          "3032069621",
          "3013660430",
          "1000487132",
          "3004145393",
          "3003917514",
          "3002637618",
          "2027969",
          "3003460426",
          "1827821",
          "8023024",
          "2247288",
          "3035708936",
          "9613069",
          "9610126",
          "3006421415",
          "2050012",
          "8023060",
          "1931251",
          "1220972",
          "1181121",
          "3005529799",
          "3008178161",
          "9612316",
          "8020316",
          "1832216",
          "3015525148",
          "3011061417",
          "3009448641",
          "3010825766",
          "2030861",
          "3006198300",
          "3002809144",
          "3005333358",
          "3023949424",
          "9680746",
          "2085064",
          "9611444"
        ],
        "fei_number": [
          "2084025",
          "3003992026",
          "3002807423",
          "3007662974",
          "3017548799",
          "3003795116",
          "3002806559",
          "3012526002",
          "3004529019",
          "3004493545",
          "2517506",
          "3043149833",
          "1219029",
          "3023162659",
          "3000215862",
          "3004445302",
          "3003422726",
          "1616487",
          "2432235",
          "3016438761",
          "2915274",
          "3014607865",
          "3006769061",
          "3043654757",
          "2050010",
          "3002806560",
          "1000125596",
          "1000122044",
          "3004111573",
          "3000206414",
          "1717966",
          "1832816",
          "3032069621",
          "3013660430",
          "1000487132",
          "3004145393",
          "3002806693",
          "3003917514",
          "3002637618",
          "3003460426",
          "1827821",
          "3035708936",
          "3002806809",
          "1000206808",
          "3003045237",
          "1000135102",
          "3006421415",
          "3003206796",
          "2050012",
          "1931251",
          "1220972",
          "1181121",
          "3005529799",
          "3008178161",
          "2967",
          "6387",
          "1832216",
          "3002808328",
          "3011061417",
          "3002698769",
          "3009448641",
          "3010825766",
          "3006198300",
          "3002809144",
          "3005333358",
          "3023949424"
        ]
      },
      "zip_code": "60069",
      "applicant": "Biosafe Laboratories, Inc.",
      "decision_date": "1999-11-26",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC",
      "advisory_committee": "HE",
      "contact": "STEVEN P TYRRELL",
      "expedited_review_flag": "",
      "k_number": "K991850",
      "state": "IL",
      "date_received": "1999-06-01",
      "review_advisory_committee": "HE",
      "postal_code": "60069",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}