Firalis SA: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Firalis SA”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SFC | Neurologic Disease Risk Assessment Molecular Test | 1 | 0 |
Review panels
- Immunology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240032 | De Novo | Neurologic Disease Risk Assessment Molecular Test | 2025-06-12 |
Recalls
openFDA lists no recalls under a recalling firm named Firalis SA.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Firalis SA?
FDA lists 0 510(k) clearances under the applicant name “Firalis SA”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Firalis SA?
The most frequent FDA product codes under this applicant name are SFC (Neurologic Disease Risk Assessment Molecular Test, 1).
Next steps
- See all 0 Firalis SA clearances with predicates and recalls
- Run predicate analysis for product code SFC, Firalis SA's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.