Roche Molecular System, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Roche Molecular System, 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.
Caduvo groups this applicant name under Roche Diagnostics, based on public ownership records.
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 |
|---|---|---|---|
| P200014 | PMA | cobas® EZH2 Mutation Test | 2020-06-18 |
Recalls
openFDA lists no recalls under a recalling firm named Roche Molecular System, 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.
- Roche Diagnostics Corp. (456 510(k)s)
- Roche Diagnostic Systems, Inc. (296 510(k)s)
- Roche Molecular Systems, Inc. (52 510(k)s)
- Roche Medical Electronics, Inc. (16 510(k)s)
- Roche Diagnostics Operations (Rdo) (14 510(k)s)
- Roche Diabetes Care, Inc. (12 510(k)s)
- Roche Analytical Instruments, Inc. (11 510(k)s)
- Roche Diagnostics Operations (7 510(k)s)
- Roche Diagnostics/Boehringer Mannheim GmbH (3 510(k)s)
- Roche (2 510(k)s)
- Roche Professional Diagnostics (2 510(k)s)
- Roche Diabetes Care AG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Roche Molecular System, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Roche Molecular System, 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 Roche Molecular System, Inc.?
The most frequent FDA product codes under this applicant name are OWD (Somatic Gene Mutation Detection System, 1).
Next steps
- See all 0 Roche Molecular System, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OWD, Roche Molecular System, 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.