Biocartis Us, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Biocartis Us, Inc.”, plus 1 PMA 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 |
|---|---|---|---|
| SFL | Nucleic Acid Based Assay, Microsatellite Instability | 1 | 0 |
Review panels
- Pathology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250005 | PMA | Idylla CDx MSI Test | 2025-08-15 |
Recalls
openFDA lists no recalls under a recalling firm named Biocartis Us, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biocartis NV (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biocartis Us, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Biocartis Us, Inc.”, plus 1 PMA 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 Biocartis Us, Inc.?
The most frequent FDA product codes under this applicant name are SFL (Nucleic Acid Based Assay, Microsatellite Instability, 1).
Next steps
- See all 0 Biocartis Us, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SFL, Biocartis Us, Inc.'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.