Bioview , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Bioview , Ltd.” (first 2003, latest 2014), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 211 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 | 1 | 415 |
| 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 |
|---|---|---|---|
| JOY | Device, Automated Cell-Locating | 4 | 4 |
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | 1 | 1 |
Review panels
- Hematology (4)
- Pathology (1)
Most recent Bioview , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130775 | DUET SYSTEM | NTH | 2014-05-09 | 415 |
| K061602 | DUET SYSTEM | JOY | 2007-01-23 | 229 |
| K050840 | MODIFICATION TO DUET SYSTEM | JOY | 2005-08-16 | 137 |
| K040591 | DUET SYSTEM | JOY | 2004-09-16 | 192 |
| K030192 | DUET SYSTEM | JOY | 2003-08-20 | 211 |
Recalls
openFDA lists no recalls under a recalling firm named Bioview , Ltd..
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 Bioview , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Bioview , Ltd.” (first 2003, latest 2014), across 2 product codes in 2 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 Bioview , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bioview , Ltd. is 211 days.
Which FDA product codes appear under Bioview , Ltd.?
The most frequent FDA product codes under this applicant name are JOY (Device, Automated Cell-Locating, 4); NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays, 1).
Next steps
- See all 5 Bioview , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JOY, Bioview , Ltd.'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.