Viramed Biotech AG: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Viramed Biotech AG” (first 2005, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time under this name: 210 days. Since 2017 the median was 226 days, against 122 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 224 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 226 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Viramed Biotech AG took a median 226 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 7 | 7 |
Review panels
- Microbiology (7)
Most recent Viramed Biotech AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220016 | Viramed Borrela All-In-One ViraChip Test Kit | LSR | 2022-08-19 | 226 |
| K163695 | Borrelia B31 ViraChip IgM Test Kit | LSR | 2017-08-22 | 237 |
| K163504 | Borrelia B31 ViraChip IgG Test Kit | LSR | 2017-07-12 | 210 |
| K092693 | VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS | LSR | 2009-11-25 | 84 |
| K082329 | VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE | LSR | 2009-08-05 | 356 |
| K051169 | BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT | LSR | 2005-08-11 | 104 |
| K051071 | VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT | LSR | 2005-08-11 | 107 |
Recalls
openFDA lists no recalls under a recalling firm named Viramed Biotech 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 Viramed Biotech AG?
FDA lists 7 510(k) clearances under the applicant name “Viramed Biotech AG” (first 2005, latest 2022), across 1 product code 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 Viramed Biotech AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Viramed Biotech AG is 210 days. Since 2017: 226 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Viramed Biotech AG?
The most frequent FDA product codes under this applicant name are LSR (Reagent, Borrelia Serological Reagent, 7).
Next steps
- See all 7 Viramed Biotech AG clearances with predicates and recalls
- Run predicate analysis for product code LSR, Viramed Biotech 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, 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.