{
  "companyId": "47950",
  "slug": "remel-inc-47950",
  "name": "Remel, Inc.",
  "clearances": {
    "total": 154,
    "last12Months": 0,
    "first": "1979-01-26",
    "latest": "2017-05-01"
  },
  "medianReviewDays": 53,
  "productCodeCount": 42,
  "recalls": {
    "total": 113,
    "openLast12Months": 4,
    "recent": [
      {
        "resNumber": "Z-2623-2026",
        "productCode": "JTY",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-06-03",
        "reason": "Reduced or no recovery of some strains of Neisseria gonorrhoeae."
      },
      {
        "resNumber": "Z-1806-2026",
        "productCode": "NGZ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-03-24",
        "reason": "Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result."
      },
      {
        "resNumber": "Z-1474-2026",
        "productCode": "JSJ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-02-05",
        "reason": "Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium."
      },
      {
        "resNumber": "Z-0585-2026",
        "productCode": "JTZ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-11-12",
        "reason": "Products may contain contamination, which may result in a darker or brown media color."
      },
      {
        "resNumber": "Z-2223-2025",
        "productCode": "JSH",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-07-11",
        "reason": "The products may contain surface and subsurface contamination of Listeria monocytogenes."
      }
    ]
  },
  "registration": {
    "sites": 1,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "JTO",
      "deviceName": "Discs, Strips And Reagents, Microorganism Differentiation",
      "clearances": 49,
      "latest": "1997-04-24",
      "medianReviewDays": 59
    },
    {
      "code": "JTN",
      "deviceName": "Susceptibility Test Discs, Antimicrobial",
      "clearances": 14,
      "latest": "1997-04-02",
      "medianReviewDays": 63
    },
    {
      "code": "JTS",
      "deviceName": "Stains, Microbiologic",
      "clearances": 12,
      "latest": "1996-03-19",
      "medianReviewDays": 51
    },
    {
      "code": "JSJ",
      "deviceName": "Culture Media, Selective And Non-Differential",
      "clearances": 11,
      "latest": "1988-03-03",
      "medianReviewDays": 39
    },
    {
      "code": "JSI",
      "deviceName": "Culture Media, Selective And Differential",
      "clearances": 9,
      "latest": "1987-06-24",
      "medianReviewDays": 29
    },
    {
      "code": "JSM",
      "deviceName": "Culture Media, Non-Propagating Transport",
      "clearances": 5,
      "latest": "1997-01-22",
      "medianReviewDays": 30
    },
    {
      "code": "JSO",
      "deviceName": "Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar",
      "clearances": 5,
      "latest": "2017-05-01",
      "medianReviewDays": 179
    },
    {
      "code": "LIO",
      "deviceName": "Device, Specimen Collection",
      "clearances": 5,
      "latest": "2001-11-26",
      "medianReviewDays": 57
    },
    {
      "code": "JSF",
      "deviceName": "Culture Media, Single Biochemical Test",
      "clearances": 4,
      "latest": "1985-04-22",
      "medianReviewDays": 37
    },
    {
      "code": "JSN",
      "deviceName": "Culture Media, Propagating Transport",
      "clearances": 2,
      "latest": "1983-12-30",
      "medianReviewDays": 32
    },
    {
      "code": "JTL",
      "deviceName": "Plasma, Coagulase, Human, Horse And Rabbit",
      "clearances": 2,
      "latest": "1984-04-13",
      "medianReviewDays": 31
    },
    {
      "code": "JWY",
      "deviceName": "Manual Antimicrobial Susceptibility Test Systems",
      "clearances": 2,
      "latest": "1991-03-05",
      "medianReviewDays": 42
    },
    {
      "code": "JXB",
      "deviceName": "Kit, Identification, Yeast",
      "clearances": 2,
      "latest": "1994-02-25",
      "medianReviewDays": 89
    },
    {
      "code": "LLH",
      "deviceName": "Reagents, Clostridium Difficile Toxin",
      "clearances": 2,
      "latest": "2004-11-15",
      "medianReviewDays": 115
    },
    {
      "code": "MHI",
      "deviceName": "Giardia Spp.",
      "clearances": 2,
      "latest": "2003-11-18",
      "medianReviewDays": 147
    },
    {
      "code": "MJD",
      "deviceName": "Culture Media, Antimycobacteria, Susceptibility Test",
      "clearances": 2,
      "latest": "1992-06-09",
      "medianReviewDays": 17
    },
    {
      "code": "GNA",
      "deviceName": "Antisera, All Types, Escherichia Coli",
      "clearances": 1,
      "latest": "1994-04-20",
      "medianReviewDays": 280
    },
    {
      "code": "GNX",
      "deviceName": "Antigens, Cf (Including Cf Control), Influenza Virus A, B, C",
      "clearances": 1,
      "latest": "2013-07-12",
      "medianReviewDays": 23
    },
    {
      "code": "GRO",
      "deviceName": "Antisera, Fluorescent, All Types, Hemophilus Spp.",
      "clearances": 1,
      "latest": "1984-01-03",
      "medianReviewDays": 39
    },
    {
      "code": "HYI",
      "deviceName": "Iodine, Grams",
      "clearances": 1,
      "latest": "1987-04-08",
      "medianReviewDays": 8
    },
    {
      "code": "IDC",
      "deviceName": "Acridine Orange",
      "clearances": 1,
      "latest": "1981-02-12",
      "medianReviewDays": 44
    },
    {
      "code": "IGB",
      "deviceName": "Solution, Formalin-Sodium Acetate",
      "clearances": 1,
      "latest": "1980-12-22",
      "medianReviewDays": 20
    },
    {
      "code": "JFO",
      "deviceName": "Fluorometric, Calcium",
      "clearances": 1,
      "latest": "1992-06-19",
      "medianReviewDays": 109
    },
    {
      "code": "JIO",
      "deviceName": "Blood, Occult, Colorimetric, In Urine",
      "clearances": 1,
      "latest": "1991-09-16",
      "medianReviewDays": 70
    },
    {
      "code": "JSD",
      "deviceName": "Culture Media, Selective Broth",
      "clearances": 1,
      "latest": "1987-05-13",
      "medianReviewDays": 30
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "42",
  "recentClearances": [
    {
      "kNumber": "K162620",
      "deviceName": "Remel Spectra ESBL",
      "productCode": "JSO",
      "decisionDate": "2017-05-01",
      "reviewDays": 223
    },
    {
      "kNumber": "K131804",
      "deviceName": "REMEL XPECT FLU A&B",
      "productCode": "GNX",
      "decisionDate": "2013-07-12",
      "reviewDays": 23
    },
    {
      "kNumber": "K092407",
      "deviceName": "REMEL SPECTRA MRSA",
      "productCode": "JSO",
      "decisionDate": "2010-10-08",
      "reviewDays": 428
    },
    {
      "kNumber": "K072827",
      "deviceName": "RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE",
      "productCode": "MJE",
      "decisionDate": "2007-11-26",
      "reviewDays": 54
    },
    {
      "kNumber": "K041951",
      "deviceName": "XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B",
      "productCode": "LLH",
      "decisionDate": "2004-11-15",
      "reviewDays": 118
    },
    {
      "kNumber": "K033479",
      "deviceName": "PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY",
      "productCode": "LLH",
      "decisionDate": "2004-02-26",
      "reviewDays": 115
    },
    {
      "kNumber": "K031942",
      "deviceName": "XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020",
      "productCode": "MHI",
      "decisionDate": "2003-11-18",
      "reviewDays": 147
    },
    {
      "kNumber": "K031965",
      "deviceName": "XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020",
      "productCode": "MHJ",
      "decisionDate": "2003-11-14",
      "reviewDays": 141
    },
    {
      "kNumber": "K031834",
      "deviceName": "XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY",
      "productCode": "MHI",
      "decisionDate": "2003-11-10",
      "reviewDays": 150
    },
    {
      "kNumber": "K031565",
      "deviceName": "XPECT INFLUENZA A/B",
      "productCode": "PSZ",
      "decisionDate": "2003-07-17",
      "reviewDays": 59
    }
  ],
  "nameVariants": {
    "total": "10",
    "shown": [
      {
        "name": "REMEL, INC.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Remel Co.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Remel Inc",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Remel Inc",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Remel Inc.",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Remel Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Remel, Inc",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Remel, Inc",
        "dataset": "device/recall",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Remel%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Remel%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": "2026-08-11T14:48:53.033Z"
}
