E.I. Dupont DE Nemours & Co., Inc.: FDA clearances and approvals
E.I. Dupont DE Nemours & Co., Inc. has 253 FDA 510(k) clearances (first 1976, latest 1996), across 127 product codes in 10 review panels. Median 510(k) review time: 48 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DLJ | Calibrators, Drug Specific | 21 | 21 |
| EAM | Screen, Intensifying, Radiographic | 11 | 11 |
| JIT | Calibrator, Secondary | 10 | 10 |
| JIS | Calibrator, Primary | 8 | 8 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 7 | 7 |
| IXA | Cassette, Radiographic Film | 6 | 6 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 5 | 5 |
| JIX | Calibrator, Multi-Analyte Mixture | 5 | 5 |
| KXT | Enzyme Immunoassay, Digoxin | 5 | 5 |
| DJY | Ion-Exchange Chromatography | 4 | 4 |
Plus 117 more product codes.
Review panels
- Clinical Toxicology (101)
- Clinical Chemistry (79)
- Radiology (26)
- Hematology (15)
- Immunology (15)
- Microbiology (7)
- Gastroenterology and Urology (2)
- Pathology (2)
- Dental (1)
- Ear, Nose and Throat (1)
Most recent E.I. Dupont DE Nemours & Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951851 | ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY | LJO | 1996-07-24 | 460 |
| K953725 | CRONEX RADIATION THERAPY VERIFICATION CASSETTE | IXA | 1995-09-06 | 27 |
| K953724 | CRONEX RADIATION THERAPY CASSETTE | IXA | 1995-09-06 | 27 |
| K951441 | DUPONT ACA DIGOXIN (DGN A) METHOD | KXT | 1995-06-01 | 64 |
| K950137 | URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE | DIS | 1995-04-13 | 90 |
| K950181 | URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE | LDJ | 1995-04-05 | 78 |
| K950136 | URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE | DJG | 1995-04-05 | 82 |
| K950135 | URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE | DKZ | 1995-03-30 | 76 |
| K950427 | URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE | JXM | 1995-03-21 | 47 |
| K950182 | URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE | DIW | 1995-03-21 | 63 |
243 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named E.I. Dupont DE Nemours & Co., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of E.I. Dupont DE Nemours & Co., Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does E.I. Dupont DE Nemours & Co., Inc. have?
E.I. Dupont DE Nemours & Co., Inc. has 253 FDA 510(k) clearances (first 1976, latest 1996), across 127 product codes in 10 review panels.
How long does FDA take to clear E.I. Dupont DE Nemours & Co., Inc.'s 510(k)s?
The median time from FDA receipt to decision across E.I. Dupont DE Nemours & Co., Inc.'s cleared 510(k)s is 48 days.
What devices does E.I. Dupont DE Nemours & Co., Inc. make?
Its most frequent FDA product codes are DLJ (Calibrators, Drug Specific, 21); EAM (Screen, Intensifying, Radiographic, 11); JIT (Calibrator, Secondary, 10).
Has E.I. Dupont DE Nemours & Co., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching E.I. Dupont DE Nemours & Co., Inc. Related entities may recall under other names.
Next steps
- See all 253 E.I. Dupont DE Nemours & Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DLJ, E.I. Dupont DE Nemours & Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.