Dupont Legal: FDA clearances and approvals
Dupont Legal has 0 FDA 510(k) clearances, plus 2 PMA decisions, across 2 product codes in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPI | Kit, Assay, Progesterone Receptor | 1 | 0 |
| LPJ | Kit, Assay, Estrogen Receptor | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P820052 | PMA | RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT | 1983-08-31 |
| P800061 | PMA | RIANEN 3H | 1981-06-01 |
Recalls
openFDA lists no recalls under a recalling firm named Dupont Legal.
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 Legal have?
Dupont Legal has 0 FDA 510(k) clearances, plus 2 PMA decisions, across 2 product codes in 1 review panel.
What devices does Dupont Legal make?
Its most frequent FDA product codes are LPI (Kit, Assay, Progesterone Receptor, 1); LPJ (Kit, Assay, Estrogen Receptor, 1).
Has Dupont Legal had device recalls?
openFDA lists no recalls under a recalling firm name matching Dupont Legal. Related entities may recall under other names.
Next steps
- See all 0 Dupont Legal clearances with predicates and recalls
- Run predicate analysis for product code LPI, Dupont Legal'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.