Roche: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Roche” (first 2011, latest 2012), plus 1 PMA decision, across 3 product codes in 3 review panels. Median 510(k) review time under this name: 138 days. 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 165 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 1 | 1 |
| OWD | Somatic Gene Mutation Detection System | 1 | 0 |
Review panels
- Clinical Chemistry (1)
- Hematology (1)
- Pathology (1)
Most recent Roche 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113793 | HOMOCYSTEINE TEST | LPS | 2012-06-05 | 165 |
| K102914 | TQ HBA1C GEN3 | LCP | 2011-01-20 | 111 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P120019 | PMA | COBAS EGFR MUTATION TEST | 2013-05-14 |
Recalls
openFDA lists no recalls under a recalling firm named Roche.
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 Professional Diagnostics (2 510(k)s)
- Roche Diabetes Care AG (1 510(k)s)
- Roche Diagnostics Hematology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Roche?
FDA lists 2 510(k) clearances under the applicant name “Roche” (first 2011, latest 2012), plus 1 PMA decision, across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Roche?
The median time from FDA receipt to decision across 510(k)s cleared under the name Roche is 138 days.
Which FDA product codes appear under Roche?
The most frequent FDA product codes under this applicant name are LCP (Assay, Glycosylated Hemoglobin, 1); LPS (Urinary Homocystine (Nonquantitative) Test System, 1); OWD (Somatic Gene Mutation Detection System, 1).
Next steps
- See all 2 Roche clearances with predicates and recalls
- Run predicate analysis for product code LCP, Roche'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.