{
  "companyId": "84436",
  "slug": "harleco-84436",
  "name": "Harleco",
  "clearances": {
    "total": 116,
    "last12Months": 0,
    "first": "1976-07-20",
    "latest": "1982-02-12"
  },
  "medianReviewDays": 25,
  "productCodeCount": 40,
  "recalls": {
    "total": 0,
    "openLast12Months": 0,
    "recent": []
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
  "productCodes": [
    {
      "code": "CGX",
      "deviceName": "Alkaline Picrate, Colorimetry, Creatinine",
      "clearances": 8,
      "latest": "1981-11-10",
      "medianReviewDays": 25
    },
    {
      "code": "CEK",
      "deviceName": "Biuret (Colorimetric), Total Protein",
      "clearances": 6,
      "latest": "1981-11-10",
      "medianReviewDays": 14
    },
    {
      "code": "CFR",
      "deviceName": "Hexokinase, Glucose",
      "clearances": 6,
      "latest": "1981-09-29",
      "medianReviewDays": 20
    },
    {
      "code": "CGS",
      "deviceName": "Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes",
      "clearances": 6,
      "latest": "1981-10-02",
      "medianReviewDays": 21
    },
    {
      "code": "CIG",
      "deviceName": "Diazo Colorimetry, Bilirubin",
      "clearances": 6,
      "latest": "1978-05-19",
      "medianReviewDays": 18
    },
    {
      "code": "CEO",
      "deviceName": "Phosphomolybdate (Colorimetric), Inorganic Phosphorus",
      "clearances": 5,
      "latest": "1977-12-06",
      "medianReviewDays": 20
    },
    {
      "code": "CIX",
      "deviceName": "Bromcresol Green Dye-Binding, Albumin",
      "clearances": 5,
      "latest": "1981-11-10",
      "medianReviewDays": 20
    },
    {
      "code": "CJE",
      "deviceName": "Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes",
      "clearances": 5,
      "latest": "1981-09-29",
      "medianReviewDays": 26
    },
    {
      "code": "CFJ",
      "deviceName": "Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase",
      "clearances": 4,
      "latest": "1981-09-24",
      "medianReviewDays": 19
    },
    {
      "code": "CIJ",
      "deviceName": "Saccharogenic, Amylase",
      "clearances": 4,
      "latest": "1981-10-02",
      "medianReviewDays": 42
    },
    {
      "code": "CJY",
      "deviceName": "Azo Dye, Calcium",
      "clearances": 4,
      "latest": "1981-11-10",
      "medianReviewDays": 18
    },
    {
      "code": "CKA",
      "deviceName": "Nadh Oxidation/Nad Reduction, Alt/Sgpt",
      "clearances": 4,
      "latest": "1981-09-24",
      "medianReviewDays": 18
    },
    {
      "code": "JMK",
      "deviceName": "Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase",
      "clearances": 4,
      "latest": "1978-02-13",
      "medianReviewDays": 24
    },
    {
      "code": "CDT",
      "deviceName": "Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides",
      "clearances": 3,
      "latest": "1981-09-24",
      "medianReviewDays": 35
    },
    {
      "code": "CGA",
      "deviceName": "Glucose Oxidase, Glucose",
      "clearances": 3,
      "latest": "1981-08-31",
      "medianReviewDays": 26
    },
    {
      "code": "CIT",
      "deviceName": "Nadh Oxidation/Nad Reduction, Ast/Sgot",
      "clearances": 3,
      "latest": "1981-09-24",
      "medianReviewDays": 19
    },
    {
      "code": "JFJ",
      "deviceName": "Catalytic Methods, Amylase",
      "clearances": 3,
      "latest": "1977-11-17",
      "medianReviewDays": 28
    },
    {
      "code": "JHW",
      "deviceName": "U.V. Method, Cpk Isoenzymes",
      "clearances": 3,
      "latest": "1981-06-25",
      "medianReviewDays": 21
    },
    {
      "code": "LFR",
      "deviceName": "Glucose Dehydrogenase, Glucose",
      "clearances": 3,
      "latest": "1981-12-31",
      "medianReviewDays": 24
    },
    {
      "code": "CHH",
      "deviceName": "Enzymatic Esterase--Oxidase, Cholesterol",
      "clearances": 2,
      "latest": "1981-11-10",
      "medianReviewDays": 13
    },
    {
      "code": "GIF",
      "deviceName": "Diluent, Blood Cell",
      "clearances": 2,
      "latest": "1978-06-14",
      "medianReviewDays": 22
    },
    {
      "code": "JMO",
      "deviceName": "Ferrozine (Colorimetric) Iron Binding Capacity",
      "clearances": 2,
      "latest": "1978-02-13",
      "medianReviewDays": 26
    },
    {
      "code": "JPZ",
      "deviceName": "Colorimetric Method, Gamma-Glutamyl Transpeptidase",
      "clearances": 2,
      "latest": "1978-03-09",
      "medianReviewDays": 48
    },
    {
      "code": "JQB",
      "deviceName": "Kinetic Method, Gamma-Glutamyl Transpeptidase",
      "clearances": 2,
      "latest": "1982-02-12",
      "medianReviewDays": 13
    },
    {
      "code": "CDO",
      "deviceName": "Acid, Uric, Uricase (U.V.)",
      "clearances": 1,
      "latest": "1981-09-23",
      "medianReviewDays": 23
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "40",
  "recentClearances": [
    {
      "kNumber": "K820233",
      "deviceName": "ULTRAZYME PLUS GAMMA GT(65055-65056)",
      "productCode": "JQB",
      "decisionDate": "1982-02-12",
      "reviewDays": 15
    },
    {
      "kNumber": "K813427",
      "deviceName": "ULTRACHEM GLUC-DH",
      "productCode": "LFR",
      "decisionDate": "1981-12-31",
      "reviewDays": 24
    },
    {
      "kNumber": "K813044",
      "deviceName": "ULTRACHEM ALB, ITEM #64970",
      "productCode": "CIX",
      "decisionDate": "1981-11-10",
      "reviewDays": 13
    },
    {
      "kNumber": "K813043",
      "deviceName": "ULTRACHEM CREA ITEM #64972",
      "productCode": "CGX",
      "decisionDate": "1981-11-10",
      "reviewDays": 13
    },
    {
      "kNumber": "K813042",
      "deviceName": "ULTRACHEM GLUC-DH SET, ITEM #65048",
      "productCode": "LFR",
      "decisionDate": "1981-11-10",
      "reviewDays": 13
    },
    {
      "kNumber": "K813041",
      "deviceName": "ULTRAZYME-GT, ITEM #64959 & 65032",
      "productCode": "JQB",
      "decisionDate": "1981-11-10",
      "reviewDays": 13
    },
    {
      "kNumber": "K813040",
      "deviceName": "ULTRACHEM CA, ITEM #64975",
      "productCode": "CJY",
      "decisionDate": "1981-11-10",
      "reviewDays": 13
    },
    {
      "kNumber": "K813039",
      "deviceName": "ULTRACHEM E-CHOL, ITEM #65025",
      "productCode": "CHH",
      "decisionDate": "1981-11-10",
      "reviewDays": 13
    },
    {
      "kNumber": "K813038",
      "deviceName": "ULTRACHEM TP, ITEM #64974",
      "productCode": "CEK",
      "decisionDate": "1981-11-10",
      "reviewDays": 13
    },
    {
      "kNumber": "K812594",
      "deviceName": "ULTRA ZYME PLUS AMYL #64982 & 65031",
      "productCode": "CIJ",
      "decisionDate": "1981-10-02",
      "reviewDays": 21
    }
  ],
  "nameVariants": {
    "total": "1",
    "shown": [
      {
        "name": "Harleco",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Harleco%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Harleco%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": "2026-08-11T14:48:53.039Z"
}
