R-Biopharm AG: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “R-Biopharm AG” (first 2017, latest 2017), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 89 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 89 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name R-Biopharm AG took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OUC | Norovirus Serological Reagent | 1 | 0 |
| PIQ | Reagents For Detection Of Norovirus Nucleic Acid | 1 | 1 |
Review panels
- Microbiology (2)
Most recent R-Biopharm AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171511 | RIDA GENE Norovirus GI/GII | PIQ | 2017-08-21 | 89 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN110001 | De Novo | Norovirus Serological Reagent | 2011-02-23 |
Recalls
openFDA lists no recalls under a recalling firm named R-Biopharm AG.
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 R-Biopharm AG?
FDA lists 1 510(k) clearance under the applicant name “R-Biopharm AG” (first 2017, latest 2017), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by R-Biopharm AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name R-Biopharm AG is 89 days.
Which FDA product codes appear under R-Biopharm AG?
The most frequent FDA product codes under this applicant name are OUC (Norovirus Serological Reagent, 1); PIQ (Reagents For Detection Of Norovirus Nucleic Acid, 1).
Next steps
- See all 1 R-Biopharm AG clearances with predicates and recalls
- Run predicate analysis for product code OUC, R-Biopharm AG'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.