Entrogen, Inc.: FDA clearances and approvals
Entrogen, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWD | Somatic Gene Mutation Detection System | 1 | 0 |
Review panels
- Pathology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220005 | PMA | CRCDx RAS Mutation Detection Assay Kit | 2023-09-29 |
Recalls
openFDA lists no recalls under a recalling firm named Entrogen, 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.
Frequently asked questions
How many FDA 510(k) clearances does Entrogen, Inc. have?
Entrogen, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Entrogen, Inc. make?
Its most frequent FDA product codes are OWD (Somatic Gene Mutation Detection System, 1).
Has Entrogen, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Entrogen, Inc. Related entities may recall under other names.
Next steps
- See all 0 Entrogen, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OWD, Entrogen, 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.