Ventana Medical Systems, Inc. (Roche Tissue Diagnostics): FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)”, plus 3 PMA decisions, across 3 product codes in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Roche Diagnostics, based on public ownership records.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QNH | Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay | 1 | 0 |
| SER | Immunohistochemistry Assay, Antibody, Met | 1 | 0 |
| SHF | 1 | 0 |
Review panels
- Pathology (2)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250031 | PMA | VENTANA PTEN (SP218) RxDx Assay | 2026-06-12 |
| P240037 | PMA | VENTANA MET (SP44) RxDx Assay | 2025-05-14 |
| P210001 | PMA | VENTANA MMR RxDx Panel | 2021-08-17 |
Recalls
openFDA lists no recalls under a recalling firm named Ventana Medical Systems, Inc. (Roche Tissue Diagnostics).
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.
- Ventana Medical Systems, Inc. (46 510(k)s)
- Ventana, Inc. (1 510(k)s)
- Ventana Medical Sytems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)?
FDA lists 0 510(k) clearances under the applicant name “Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)”, plus 3 PMA decisions, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)?
The most frequent FDA product codes under this applicant name are QNH (Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay, 1); SER (Immunohistochemistry Assay, Antibody, Met, 1); SHF (device, 1).
Next steps
- See all 0 Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) clearances with predicates and recalls
- Run predicate analysis for product code QNH, Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)'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.