Panbio Limited: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Panbio Limited” (first 2003, latest 2004), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 101 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 |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| NOP | Elisa, Antibody, West Nile Virus | 3 | 2 |
| LSE | Epstein-Barr Virus, Other | 1 | 1 |
Review panels
- Microbiology (4)
Most recent Panbio Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041068 | WEST NILE VIRUS IGG INDIRECT ELISA | NOP | 2004-10-20 | 177 |
| K041231 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M | NOP | 2004-08-10 | 92 |
| K030863 | EBV VCA-P18 IGG ELISA | LSE | 2003-06-27 | 101 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN030004 | De Novo | Elisa, Antibody, West Nile Virus | 2003-07-08 |
Recalls
openFDA lists no recalls under a recalling firm named Panbio Limited.
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.
- Panbio, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Panbio Limited?
FDA lists 3 510(k) clearances under the applicant name “Panbio Limited” (first 2003, latest 2004), 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 Panbio Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Panbio Limited is 101 days.
Which FDA product codes appear under Panbio Limited?
The most frequent FDA product codes under this applicant name are NOP (Elisa, Antibody, West Nile Virus, 3); LSE (Epstein-Barr Virus, Other, 1).
Next steps
- See all 3 Panbio Limited clearances with predicates and recalls
- Run predicate analysis for product code NOP, Panbio Limited'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.