{
  "companyId": "52347",
  "slug": "wako-chemicals-usa-inc-52347",
  "name": "Wako Chemicals USA, Inc.",
  "clearances": {
    "total": 123,
    "last12Months": 0,
    "first": "1981-06-09",
    "latest": "2011-02-23"
  },
  "medianReviewDays": 52,
  "productCodeCount": 58,
  "recalls": {
    "total": 3,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1377-2012",
        "productCode": "DFC",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2012-01-30",
        "reason": "In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease."
      },
      {
        "resNumber": "Z-1071-2007",
        "productCode": "JIT",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2007-03-30",
        "reason": "Diagnostic reagent for clinical laboratory testing was incorrectly labeled."
      },
      {
        "resNumber": "Z-1409-06",
        "productCode": "MMY",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2006-07-06",
        "reason": "Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value."
      }
    ]
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
  "productCodes": [
    {
      "code": "JIT",
      "deviceName": "Calibrator, Secondary",
      "clearances": 15,
      "latest": "2004-04-23",
      "medianReviewDays": 21
    },
    {
      "code": "DFC",
      "deviceName": "Lipoprotein, Low-Density, Antigen, Antiserum, Control",
      "clearances": 9,
      "latest": "2000-07-24",
      "medianReviewDays": 30
    },
    {
      "code": "JIS",
      "deviceName": "Calibrator, Primary",
      "clearances": 7,
      "latest": "2003-04-11",
      "medianReviewDays": 64
    },
    {
      "code": "JIX",
      "deviceName": "Calibrator, Multi-Analyte Mixture",
      "clearances": 4,
      "latest": "2004-11-16",
      "medianReviewDays": 49
    },
    {
      "code": "JJX",
      "deviceName": "Single (Specified) Analyte Controls (Assayed And Unassayed)",
      "clearances": 4,
      "latest": "2004-05-17",
      "medianReviewDays": 35
    },
    {
      "code": "KNK",
      "deviceName": "Acid, Uric, Uricase (Colorimetric)",
      "clearances": 4,
      "latest": "1999-11-09",
      "medianReviewDays": 27
    },
    {
      "code": "CEK",
      "deviceName": "Biuret (Colorimetric), Total Protein",
      "clearances": 3,
      "latest": "1992-07-14",
      "medianReviewDays": 118
    },
    {
      "code": "CHH",
      "deviceName": "Enzymatic Esterase--Oxidase, Cholesterol",
      "clearances": 3,
      "latest": "1988-03-01",
      "medianReviewDays": 39
    },
    {
      "code": "CIT",
      "deviceName": "Nadh Oxidation/Nad Reduction, Ast/Sgot",
      "clearances": 3,
      "latest": "1999-12-16",
      "medianReviewDays": 64
    },
    {
      "code": "DCK",
      "deviceName": "C-Reactive Protein, Antigen, Antiserum, And Control",
      "clearances": 3,
      "latest": "2003-06-06",
      "medianReviewDays": 95
    },
    {
      "code": "JFM",
      "deviceName": "Enzymatic Method, Bilirubin",
      "clearances": 3,
      "latest": "2005-12-30",
      "medianReviewDays": 52
    },
    {
      "code": "CDQ",
      "deviceName": "Urease And Glutamic Dehydrogenase, Urea Nitrogen",
      "clearances": 2,
      "latest": "2000-04-03",
      "medianReviewDays": 44
    },
    {
      "code": "CFM",
      "deviceName": "Bathophenanthroline, Colorimetry, Iron (Non-Heme)",
      "clearances": 2,
      "latest": "1999-01-15",
      "medianReviewDays": 34
    },
    {
      "code": "CFN",
      "deviceName": "Method, Nephelometric, Immunoglobulins (G, A, M)",
      "clearances": 2,
      "latest": "2000-01-14",
      "medianReviewDays": 56
    },
    {
      "code": "CFR",
      "deviceName": "Hexokinase, Glucose",
      "clearances": 2,
      "latest": "2008-07-17",
      "medianReviewDays": 63
    },
    {
      "code": "CGA",
      "deviceName": "Glucose Oxidase, Glucose",
      "clearances": 2,
      "latest": "1995-10-05",
      "medianReviewDays": 79
    },
    {
      "code": "CHI",
      "deviceName": "Lipase-Esterase, Enzymatic, Photometric, Lipase",
      "clearances": 2,
      "latest": "1992-07-21",
      "medianReviewDays": 40
    },
    {
      "code": "CIC",
      "deviceName": "Cresolphthalein Complexone, Calcium",
      "clearances": 2,
      "latest": "1987-10-02",
      "medianReviewDays": 14
    },
    {
      "code": "CIG",
      "deviceName": "Diazo Colorimetry, Bilirubin",
      "clearances": 2,
      "latest": "1997-05-07",
      "medianReviewDays": 50
    },
    {
      "code": "CKA",
      "deviceName": "Nadh Oxidation/Nad Reduction, Alt/Sgpt",
      "clearances": 2,
      "latest": "1987-01-09",
      "medianReviewDays": 30
    },
    {
      "code": "CZP",
      "deviceName": "Iga, Antigen, Antiserum, Control",
      "clearances": 2,
      "latest": "2000-01-14",
      "medianReviewDays": 29
    },
    {
      "code": "DCN",
      "deviceName": "System, Test, C-Reactive Protein",
      "clearances": 2,
      "latest": "2001-01-22",
      "medianReviewDays": 29
    },
    {
      "code": "DEW",
      "deviceName": "Igg, Antigen, Antiserum, Control",
      "clearances": 2,
      "latest": "2000-01-18",
      "medianReviewDays": 61
    },
    {
      "code": "DHR",
      "deviceName": "System, Test, Rheumatoid Factor",
      "clearances": 2,
      "latest": "2002-09-09",
      "medianReviewDays": 82
    },
    {
      "code": "JFJ",
      "deviceName": "Catalytic Methods, Amylase",
      "clearances": 2,
      "latest": "1999-01-13",
      "medianReviewDays": 51
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "58",
  "recentClearances": [
    {
      "kNumber": "K100464",
      "deviceName": "UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION",
      "productCode": "NSF",
      "decisionDate": "2011-02-23",
      "reviewDays": 370
    },
    {
      "kNumber": "K080125",
      "deviceName": "APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201",
      "productCode": "LBS",
      "decisionDate": "2008-07-18",
      "reviewDays": 183
    },
    {
      "kNumber": "K080123",
      "deviceName": "APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201",
      "productCode": "CFR",
      "decisionDate": "2008-07-17",
      "reviewDays": 182
    },
    {
      "kNumber": "K061775",
      "deviceName": "WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR",
      "productCode": "JFY",
      "decisionDate": "2007-02-23",
      "reviewDays": 245
    },
    {
      "kNumber": "K062368",
      "deviceName": "WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401",
      "productCode": "OAU",
      "decisionDate": "2007-01-31",
      "reviewDays": 170
    },
    {
      "kNumber": "K053132",
      "deviceName": "WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791",
      "productCode": "JFM",
      "decisionDate": "2005-12-30",
      "reviewDays": 52
    },
    {
      "kNumber": "K053131",
      "deviceName": "WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191",
      "productCode": "JFM",
      "decisionDate": "2005-12-30",
      "reviewDays": 52
    },
    {
      "kNumber": "K042551",
      "deviceName": "MULTI-CHEM CALIBRATOR A",
      "productCode": "JIX",
      "decisionDate": "2004-11-16",
      "reviewDays": 57
    },
    {
      "kNumber": "K042550",
      "deviceName": "MULTI-LIPID CALIBRATOR",
      "productCode": "JIX",
      "decisionDate": "2004-11-08",
      "reviewDays": 49
    },
    {
      "kNumber": "K042549",
      "deviceName": "MULTI CHEM CAL B",
      "productCode": "JIX",
      "decisionDate": "2004-11-08",
      "reviewDays": 49
    }
  ],
  "nameVariants": {
    "total": "3",
    "shown": [
      {
        "name": "Wako Chemicals USA, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Wako Chemicals USA, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Wako Chemicals, USA Inc",
        "dataset": "device/recall",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Wako%20Chemicals%20USA%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Wako%20Chemicals%20USA%2C%20Inc.%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": "2026-08-11T14:48:53.038Z"
}
