{
  "code": "KIT",
  "deviceName": "Media And Components, Synthetic Cell And Tissue Culture",
  "deviceClass": "I",
  "regulationNumber": "864.2220",
  "panel": "Hematology",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 367,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 0,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 20,
    "sampleSize": 367
  },
  "recalls": {
    "total": 4,
    "recent": [
      {
        "resNumber": "Z-0171-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Life Technologies Corporation",
        "firmAsPublished": "Life Technologies, Corp.",
        "reason": "Leaky bottles due to a defect in the bottle cap compromising the sterility of the product",
        "initiated": "2018-08-24"
      },
      {
        "resNumber": "Z-0172-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Life Technologies Corporation",
        "firmAsPublished": "Life Technologies, Corp.",
        "reason": "Leaky bottles due to a defect in the bottle cap compromising the sterility of the product",
        "initiated": "2018-08-24"
      },
      {
        "resNumber": "Z-0173-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Life Technologies Corporation",
        "firmAsPublished": "Life Technologies, Corp.",
        "reason": "Leaky bottles due to a defect in the bottle cap compromising the sterility of the product",
        "initiated": "2018-08-24"
      },
      {
        "resNumber": "Z-0174-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Life Technologies Corporation",
        "firmAsPublished": "Life Technologies, Corp.",
        "reason": "Leaky bottles due to a defect in the bottle cap compromising the sterility of the product",
        "initiated": "2018-08-24"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K892938",
      "deviceName": "AMNIO-GROW TM",
      "applicant": "Inovar Biologicals, Inc.",
      "company": "Inovar Biologicals, Inc.",
      "decisionDate": "1989-05-22",
      "dateReceived": "1989-04-21"
    },
    {
      "kNumber": "K890701",
      "deviceName": "ENDOTHELIAL GROWTH MEDIUM (EGM)",
      "applicant": "Clonetics Corp.",
      "company": "Clonetics Corp.",
      "decisionDate": "1989-02-24",
      "dateReceived": "1989-02-10"
    },
    {
      "kNumber": "K890700",
      "deviceName": "MELANOCYTE GROWTH MEDIUM (MGM)",
      "applicant": "Clonetics Corp.",
      "company": "Clonetics Corp.",
      "decisionDate": "1989-02-24",
      "dateReceived": "1989-02-10"
    },
    {
      "kNumber": "K890482",
      "deviceName": "ABC, ABC-1X, ABC(TM)",
      "applicant": "Cell Ent., Inc.",
      "company": "Cell Ent., Inc.",
      "decisionDate": "1989-02-10",
      "dateReceived": "1989-01-31"
    },
    {
      "kNumber": "K884654",
      "deviceName": "ALPHACALF SERUM",
      "applicant": "Hyclone Laboratories, Inc.",
      "company": "Hyclone Laboratories, Inc.",
      "decisionDate": "1988-11-30",
      "dateReceived": "1988-11-07"
    },
    {
      "kNumber": "K884574",
      "deviceName": "DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785",
      "applicant": "Sigma Chemical Co.",
      "company": "Sigma Chemical Co.",
      "decisionDate": "1988-11-22",
      "dateReceived": "1988-11-01"
    },
    {
      "kNumber": "K884573",
      "deviceName": "HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891",
      "applicant": "Sigma Chemical Co.",
      "company": "Sigma Chemical Co.",
      "decisionDate": "1988-11-22",
      "dateReceived": "1988-11-01"
    },
    {
      "kNumber": "K884572",
      "deviceName": "RPMI-1640 HYBRI-MAX, PROD. NO. R5382",
      "applicant": "Sigma Chemical Co.",
      "company": "Sigma Chemical Co.",
      "decisionDate": "1988-11-22",
      "dateReceived": "1988-11-01"
    },
    {
      "kNumber": "K883065",
      "deviceName": "ALLOPREP SYSTEM",
      "applicant": "Osteotech, Inc.",
      "company": "Osteotech Inc",
      "decisionDate": "1988-10-13",
      "dateReceived": "1988-07-20"
    },
    {
      "kNumber": "K884031",
      "deviceName": "FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT",
      "applicant": "Regency Biotech",
      "company": "Regency Biotech",
      "decisionDate": "1988-10-06",
      "dateReceived": "1988-09-23"
    }
  ],
  "topApplicants": [
    {
      "name": "J R Scientific",
      "count": 132
    },
    {
      "name": "Sigma Chemical Co.",
      "count": 87
    },
    {
      "name": "Dutchland Laboratories, Inc.",
      "count": 42
    },
    {
      "name": "Hazleton Research Products, Inc.",
      "count": 34
    },
    {
      "name": "Mediatech, Inc.",
      "count": 23
    }
  ],
  "topCompanies": [
    {
      "name": "J R Scientific",
      "count": 132,
      "spellings": 1
    },
    {
      "name": "Sigma Chemical Co.",
      "count": 87,
      "spellings": 1
    },
    {
      "name": "Dutchland Laboratories, Inc.",
      "count": 42,
      "spellings": 1
    },
    {
      "name": "Hazleton Research Products, Inc.",
      "count": 34,
      "spellings": 1
    },
    {
      "name": "Mediatech, Inc.",
      "count": 23,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "KIT (Media And Components, Synthetic Cell And Tissue Culture): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AKIT"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKIT"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKIT"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKIT"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKIT"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKIT"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKIT"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.731Z"
}