Dupont Medical Products: FDA clearances and approvals
Dupont Medical Products has 28 FDA 510(k) clearances (first 1991, latest 1995), across 24 product codes in 4 review panels. Median 510(k) review time: 97 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 |
|---|---|---|---|
| IXA | Cassette, Radiographic Film | 2 | 2 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 2 | 2 |
| JIS | Calibrator, Primary | 2 | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 1 | 1 |
Plus 14 more product codes.
Review panels
- Clinical Chemistry (19)
- Radiology (4)
- Clinical Toxicology (3)
- Immunology (2)
Most recent Dupont Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952815 | DUPONT LIPASE CALIBRATOR | JIT | 1995-08-31 | 72 |
| K950920 | DUPONT DIMENSION TOTAL PROTEIN METHOD | CEK | 1995-08-11 | 163 |
| K952816 | LIPASE FLEX REAGENT CARTRIDGE | CHI | 1995-07-20 | 30 |
| K952412 | DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL | DIF | 1995-06-23 | 31 |
| K945280 | DUPONT DIMENSION C-REACTIVE PROTEIN METHOD | DCK | 1995-03-09 | 132 |
| K944932 | PHENOBARBITAL FLEX REAGENT CARTRIDGE | DLZ | 1994-12-28 | 83 |
| K941050 | DUPONT ACA STAR | JJQ | 1994-11-10 | 248 |
| K943996 | DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD | CEP | 1994-10-20 | 65 |
| K941146 | DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM | JLW | 1994-10-03 | 207 |
| K942640 | DUPONT DIMENSION AMYLASE METHOD | JFJ | 1994-09-09 | 98 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dupont Medical Products.
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.
Frequently asked questions
How many FDA 510(k) clearances does Dupont Medical Products have?
Dupont Medical Products has 28 FDA 510(k) clearances (first 1991, latest 1995), across 24 product codes in 4 review panels.
How long does FDA take to clear Dupont Medical Products's 510(k)s?
The median time from FDA receipt to decision across Dupont Medical Products's cleared 510(k)s is 97 days.
What devices does Dupont Medical Products make?
Its most frequent FDA product codes are IXA (Cassette, Radiographic Film, 2); JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes, 2); JIS (Calibrator, Primary, 2).
Has Dupont Medical Products had device recalls?
openFDA lists no recalls under a recalling firm name matching Dupont Medical Products. Related entities may recall under other names.
Next steps
- See all 28 Dupont Medical Products clearances with predicates and recalls
- Run predicate analysis for product code IXA, Dupont Medical Products'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.