Medical device manufacturer
E.I. Dupont DE Nemours & Co., Inc.
E.I. Dupont DE Nemours & Co., Inc. holds 253 FDA 510(k) clearances across 126 product codes. Median elapsed review time is 48 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 253
- Product codes
- 126
- Median review
- 48 days
- Recall records
- 0
How does FDA spell E.I. Dupont DE Nemours & Co., Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does E.I. Dupont DE Nemours & Co., Inc. file in?
126 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DLJ | Calibrators, Drug Specific | 21 | 34 days | |
| EAM | Screen, Intensifying, Radiographic | 11 | 61 days | |
| JIT | Calibrator, Secondary | 10 | 32 days | |
| JIS | Calibrator, Primary | 8 | 42 days | |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 7 | 68 days | |
| IXA | Cassette, Radiographic Film | 6 | 27 days | |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 5 | 63 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 5 | 62 days | |
| KXT | Enzyme Immunoassay, Digoxin | 5 | 56 days | |
| DJY | Ion-Exchange Chromatography | 4 | 27 days | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 | 26 days | |
| CIG | Diazo Colorimetry, Bilirubin | 3 | 57 days | |
| DIF | Drug Mixture Control Materials | 3 | 36 days | |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 3 | 26 days | |
| DIS | Enzyme Immunoassay, Barbiturate | 3 | 52 days | |
| DKB | Calibrators, Drug Mixture | 3 | 58 days | |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 3 | 33 days | |
| JQP | Calculator/Data Processing Module, For Clinical Use | 3 | 48 days | |
| JXM | Enzyme Immunoassay, Benzodiazepine | 3 | 47 days | |
| KLB | Radioimmunoassay, Tobramycin | 3 | 37 days | |
| KLS | Enzyme Immunoassay, Theophylline | 3 | 51 days | |
| LAS | Drug Specific Control Materials | 3 | 76 days | |
| LCD | Enzyme Immunoassay, Gentamicin | 3 | 26 days | |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 2 | 49 days | |
| CFE | Electrophoretic, Lactate Dehydrogenase Isoenzymes | 2 | 33 days |
Showing the 25 they file in most, of 126.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has E.I. Dupont DE Nemours & Co., Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has E.I. Dupont DE Nemours & Co., Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K951851 | ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY | LJO | 460 | |
| K953725 | CRONEX RADIATION THERAPY VERIFICATION CASSETTE | IXA | 27 | |
| K953724 | CRONEX RADIATION THERAPY CASSETTE | IXA | 27 | |
| K951441 | DUPONT ACA DIGOXIN (DGN A) METHOD | KXT | 64 | |
| K950137 | URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE | DIS | 90 | |
| K950181 | URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE | LDJ | 78 | |
| K950136 | URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE | DJG | 82 | |
| K950135 | URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE | DKZ | 76 | |
| K950427 | URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE | JXM | 47 | |
| K950182 | URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE | DIW | 63 |
Source: openFDA device/510k · retrieved
Watch what E.I. Dupont DE Nemours & Co., Inc. files next
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