{
  "companyId": "49741",
  "slug": "acumedia-manufacturers-inc-49741",
  "name": "Acumedia Manufacturers, Inc.",
  "clearances": {
    "total": 177,
    "last12Months": 0,
    "first": "1981-04-29",
    "latest": "1988-04-18"
  },
  "medianReviewDays": 14,
  "productCodeCount": 18,
  "recalls": {
    "total": 8,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-0283-2019",
        "productCode": "JSI",
        "status": "Terminated",
        "recallClass": "Class III",
        "initiated": "2018-08-02",
        "reason": "Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021."
      },
      {
        "resNumber": "Z-0284-2019",
        "productCode": "JSJ",
        "status": "Terminated",
        "recallClass": "Class III",
        "initiated": "2018-08-02",
        "reason": "The product is labeled with an incorrect expiration date."
      },
      {
        "resNumber": "Z-2221-2017",
        "productCode": "JSI",
        "status": "Terminated",
        "recallClass": "Class III",
        "initiated": "2016-09-25",
        "reason": "Storage temperature listed on the label was incorrect. Label stated 2-30C.\nActual storage temperature is 2-8C."
      },
      {
        "resNumber": "Z-2212-2017",
        "productCode": "JSG",
        "status": "Terminated",
        "recallClass": "Class III",
        "initiated": "2016-08-08",
        "reason": "Storage temperature listed on the label was incorrect. Label stated\n2-30C. Actual storage temperature is 2-8C."
      },
      {
        "resNumber": "Z-1093-2017",
        "productCode": "JSG",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2016-04-22",
        "reason": "light precipitate may form in prepared plates of Acumedia Tryptic\r\nSoy Agar (7100) Lot#  108166.\r\nWhile there is no change in growth performance of this medium, the formation\r\nof particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate\r\ncounts."
      }
    ]
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
  "productCodes": [
    {
      "code": "JSG",
      "deviceName": "Culture Media, Non-Selective And Non-Differential",
      "clearances": 42,
      "latest": "1988-04-18",
      "medianReviewDays": 11
    },
    {
      "code": "JSI",
      "deviceName": "Culture Media, Selective And Differential",
      "clearances": 40,
      "latest": "1988-04-18",
      "medianReviewDays": 17
    },
    {
      "code": "JSJ",
      "deviceName": "Culture Media, Selective And Non-Differential",
      "clearances": 30,
      "latest": "1988-04-18",
      "medianReviewDays": 11
    },
    {
      "code": "JSH",
      "deviceName": "Culture Media, Non-Selective And Differential",
      "clearances": 21,
      "latest": "1988-04-18",
      "medianReviewDays": 29
    },
    {
      "code": "JSK",
      "deviceName": "Supplement, Culture Media",
      "clearances": 10,
      "latest": "1988-04-18",
      "medianReviewDays": 15
    },
    {
      "code": "JSA",
      "deviceName": "Culture Media, Antibiotic Assay",
      "clearances": 8,
      "latest": "1988-04-18",
      "medianReviewDays": 10
    },
    {
      "code": "JSC",
      "deviceName": "Culture Media, General Nutrient Broth",
      "clearances": 6,
      "latest": "1983-11-07",
      "medianReviewDays": 16
    },
    {
      "code": "JSM",
      "deviceName": "Culture Media, Non-Propagating Transport",
      "clearances": 3,
      "latest": "1988-04-18",
      "medianReviewDays": 10
    },
    {
      "code": "JTY",
      "deviceName": "Culture Media, For Isolation Of Pathogenic Neisseria",
      "clearances": 3,
      "latest": "1988-04-18",
      "medianReviewDays": 10
    },
    {
      "code": "JSO",
      "deviceName": "Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar",
      "clearances": 2,
      "latest": "1988-04-18",
      "medianReviewDays": 7
    },
    {
      "code": "JTZ",
      "deviceName": "Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth",
      "clearances": 2,
      "latest": "1981-05-05",
      "medianReviewDays": 11
    },
    {
      "code": "LKA",
      "deviceName": "Culture Media, Antimicrobial Susceptibility Test",
      "clearances": 2,
      "latest": "1983-10-27",
      "medianReviewDays": 38
    },
    {
      "code": "JAK",
      "deviceName": "System, X-Ray, Tomography, Computed",
      "clearances": 1,
      "latest": "1981-05-29",
      "medianReviewDays": 15
    },
    {
      "code": "JKS",
      "deviceName": "Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide",
      "clearances": 1,
      "latest": "1983-10-27",
      "medianReviewDays": 38
    },
    {
      "code": "JSD",
      "deviceName": "Culture Media, Selective Broth",
      "clearances": 1,
      "latest": "1981-05-28",
      "medianReviewDays": 16
    },
    {
      "code": "JSE",
      "deviceName": "Culture Media, Multiple Biochemical Test",
      "clearances": 1,
      "latest": "1983-09-12",
      "medianReviewDays": 41
    },
    {
      "code": "JSN",
      "deviceName": "Culture Media, Propagating Transport",
      "clearances": 1,
      "latest": "1988-04-18",
      "medianReviewDays": 7
    },
    {
      "code": "JSQ",
      "deviceName": "Chromatography For Bacterial Identification",
      "clearances": 1,
      "latest": "1981-05-05",
      "medianReviewDays": 11
    }
  ],
  "productCodesShown": 18,
  "productCodesTotal": "18",
  "recentClearances": [
    {
      "kNumber": "K881579",
      "deviceName": "AMIES TRANSPORT MEDIUM W/O CHARCOAL",
      "productCode": "JSN",
      "decisionDate": "1988-04-18",
      "reviewDays": 7
    },
    {
      "kNumber": "K881578",
      "deviceName": "STREPTOSEL",
      "productCode": "JSJ",
      "decisionDate": "1988-04-18",
      "reviewDays": 7
    },
    {
      "kNumber": "K881577",
      "deviceName": "MODIFIED SELECTIVE STREPTOCOCCUS AGAR",
      "productCode": "JSI",
      "decisionDate": "1988-04-18",
      "reviewDays": 7
    },
    {
      "kNumber": "K881576",
      "deviceName": "SELENITE BROTH",
      "productCode": "JSI",
      "decisionDate": "1988-04-18",
      "reviewDays": 7
    },
    {
      "kNumber": "K881575",
      "deviceName": "SELECTIVE STREPTOCOCCUS AGAR",
      "productCode": "JSI",
      "decisionDate": "1988-04-18",
      "reviewDays": 7
    },
    {
      "kNumber": "K881574",
      "deviceName": "W-L DIFFERENTIAL MEDIUM",
      "productCode": "JSJ",
      "decisionDate": "1988-04-18",
      "reviewDays": 7
    },
    {
      "kNumber": "K881573",
      "deviceName": "PHYTONE YEAST EXTRACT AGAR",
      "productCode": "JSJ",
      "decisionDate": "1988-04-18",
      "reviewDays": 7
    },
    {
      "kNumber": "K881572",
      "deviceName": "XL AGAR BASE",
      "productCode": "JSI",
      "decisionDate": "1988-04-18",
      "reviewDays": 7
    },
    {
      "kNumber": "K881571",
      "deviceName": "YM BROTH",
      "productCode": "JSJ",
      "decisionDate": "1988-04-18",
      "reviewDays": 7
    },
    {
      "kNumber": "K881570",
      "deviceName": "SABOURAUD MALTOSE AGAR",
      "productCode": "JSJ",
      "decisionDate": "1988-04-18",
      "reviewDays": 7
    }
  ],
  "nameVariants": {
    "total": "3",
    "shown": [
      {
        "name": "Acumedia Manufacturers, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Acumedia Manufacturers, Inc.",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Acumedia Manufacturers, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Acumedia%20Manufacturers%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Acumedia%20Manufacturers%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": "2026-08-11T14:48:53.031Z"
}