{
  "companyId": "59752",
  "slug": "bayer-corp-59752",
  "name": "Bayer Corp.",
  "clearances": {
    "total": 96,
    "last12Months": 0,
    "first": "1989-06-16",
    "latest": "2003-03-03"
  },
  "medianReviewDays": 74,
  "productCodeCount": 60,
  "recalls": {
    "total": 2,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1673-2014",
        "productCode": "FRN",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2014-04-03",
        "reason": "There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008."
      },
      {
        "resNumber": "Z-0066-04",
        "productCode": "CHL",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2003-09-26",
        "reason": "Potential for bias shift in pO2 values due to air bubble in sample path"
      }
    ]
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
  "productCodes": [
    {
      "code": "CGA",
      "deviceName": "Glucose Oxidase, Glucose",
      "clearances": 8,
      "latest": "2003-03-03",
      "medianReviewDays": 84
    },
    {
      "code": "JIR",
      "deviceName": "Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)",
      "clearances": 4,
      "latest": "1999-11-24",
      "medianReviewDays": 49
    },
    {
      "code": "LTJ",
      "deviceName": "Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers",
      "clearances": 4,
      "latest": "2002-12-17",
      "medianReviewDays": 83
    },
    {
      "code": "MMI",
      "deviceName": "Immunoassay Method, Troponin Subunit",
      "clearances": 4,
      "latest": "2001-03-29",
      "medianReviewDays": 63
    },
    {
      "code": "CFR",
      "deviceName": "Hexokinase, Glucose",
      "clearances": 3,
      "latest": "2001-11-20",
      "medianReviewDays": 126
    },
    {
      "code": "GKZ",
      "deviceName": "Counter, Differential Cell",
      "clearances": 3,
      "latest": "2001-02-05",
      "medianReviewDays": 59
    },
    {
      "code": "LFX",
      "deviceName": "Enzyme Linked Immunoabsorbent Assay, Rubella",
      "clearances": 3,
      "latest": "2001-07-05",
      "medianReviewDays": 162
    },
    {
      "code": "LGD",
      "deviceName": "Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii",
      "clearances": 3,
      "latest": "2001-08-20",
      "medianReviewDays": 160
    },
    {
      "code": "LTK",
      "deviceName": "Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)",
      "clearances": 3,
      "latest": "2002-07-24",
      "medianReviewDays": 205
    },
    {
      "code": "NBW",
      "deviceName": "System, Test, Blood Glucose, Over The Counter",
      "clearances": 3,
      "latest": "2003-01-23",
      "medianReviewDays": 31
    },
    {
      "code": "CIX",
      "deviceName": "Bromcresol Green Dye-Binding, Albumin",
      "clearances": 2,
      "latest": "1999-09-15",
      "medianReviewDays": 55
    },
    {
      "code": "GKL",
      "deviceName": "Counter, Cell, Automated (Particle Counter)",
      "clearances": 2,
      "latest": "1997-08-29",
      "medianReviewDays": 91
    },
    {
      "code": "JHI",
      "deviceName": "Visual, Pregnancy Hcg, Prescription Use",
      "clearances": 2,
      "latest": "2003-02-11",
      "medianReviewDays": 2
    },
    {
      "code": "JJE",
      "deviceName": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",
      "clearances": 2,
      "latest": "1998-12-07",
      "medianReviewDays": 60
    },
    {
      "code": "JZG",
      "deviceName": "System, Test, Beta-2-Microglobulin Immunological",
      "clearances": 2,
      "latest": "1999-12-16",
      "medianReviewDays": 43
    },
    {
      "code": "KLT",
      "deviceName": "Enzyme Immunoassay, Carbamazepine",
      "clearances": 2,
      "latest": "2000-05-18",
      "medianReviewDays": 58
    },
    {
      "code": "LOJ",
      "deviceName": "Kit, Test,Alpha-Fetoprotein For Testicular Cancer",
      "clearances": 2,
      "latest": "2002-03-27",
      "medianReviewDays": 15
    },
    {
      "code": "NCW",
      "deviceName": "System, Test, Her-2/Neu, Monitoring",
      "clearances": 2,
      "latest": "2003-01-30",
      "medianReviewDays": 57
    },
    {
      "code": "CDD",
      "deviceName": "Radioassay, Vitamin B12",
      "clearances": 1,
      "latest": "1999-12-16",
      "medianReviewDays": 56
    },
    {
      "code": "CDP",
      "deviceName": "Radioimmunoassay, Total Triiodothyronine",
      "clearances": 1,
      "latest": "1996-07-12",
      "medianReviewDays": 24
    },
    {
      "code": "CDZ",
      "deviceName": "Radioimmunoassay, Testosterones And Dihydrotestosterone",
      "clearances": 1,
      "latest": "1996-09-27",
      "medianReviewDays": 50
    },
    {
      "code": "CGI",
      "deviceName": "Radioimmunoassay, Estriol",
      "clearances": 1,
      "latest": "1998-03-03",
      "medianReviewDays": 75
    },
    {
      "code": "CGN",
      "deviceName": "Acid, Folic, Radioimmunoassay",
      "clearances": 1,
      "latest": "1996-01-24",
      "medianReviewDays": 128
    },
    {
      "code": "CHL",
      "deviceName": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph",
      "clearances": 1,
      "latest": "2000-12-19",
      "medianReviewDays": 109
    },
    {
      "code": "CHP",
      "deviceName": "Radioimmunoassay, Estradiol",
      "clearances": 1,
      "latest": "1995-05-02",
      "medianReviewDays": 36
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "60",
  "recentClearances": [
    {
      "kNumber": "K024062",
      "deviceName": "ASCENSIA BREEZE BLOOD GLUCOSE METER",
      "productCode": "CGA",
      "decisionDate": "2003-03-03",
      "reviewDays": 84
    },
    {
      "kNumber": "K023944",
      "deviceName": "BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST",
      "productCode": "JHI",
      "decisionDate": "2003-02-11",
      "reviewDays": 77
    },
    {
      "kNumber": "K024017",
      "deviceName": "BAYER ADVIA CENTAUR HER-2/NEU ASSAY",
      "productCode": "NCW",
      "decisionDate": "2003-01-30",
      "reviewDays": 57
    },
    {
      "kNumber": "K024234",
      "deviceName": "ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL",
      "productCode": "NBW",
      "decisionDate": "2003-01-23",
      "reviewDays": 31
    },
    {
      "kNumber": "K022288",
      "deviceName": "COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM",
      "productCode": "LTJ",
      "decisionDate": "2002-12-17",
      "reviewDays": 155
    },
    {
      "kNumber": "K023584",
      "deviceName": "ASCENSIA DEX 2 DIABETES CARE SYSTEM",
      "productCode": "NBW",
      "decisionDate": "2002-11-20",
      "reviewDays": 26
    },
    {
      "kNumber": "K020828",
      "deviceName": "CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM",
      "productCode": "LTK",
      "decisionDate": "2002-07-24",
      "reviewDays": 132
    },
    {
      "kNumber": "K021428",
      "deviceName": "CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM",
      "productCode": "JFY",
      "decisionDate": "2002-07-05",
      "reviewDays": 63
    },
    {
      "kNumber": "K020806",
      "deviceName": "ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY",
      "productCode": "LOJ",
      "decisionDate": "2002-03-27",
      "reviewDays": 15
    },
    {
      "kNumber": "K013568",
      "deviceName": "CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM",
      "productCode": "DHX",
      "decisionDate": "2001-12-21",
      "reviewDays": 56
    }
  ],
  "nameVariants": {
    "total": "4",
    "shown": [
      {
        "name": "Bayer Corp",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Bayer Corp",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Bayer Corp.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Bayer Corp.",
        "dataset": "device/recall",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Bayer%20Corp.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Bayer%20Corp.%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.047Z"
}