Wieslab AB: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Wieslab AB” (first 1998, latest 1998), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 104 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 |
|---|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 4 | 4 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
Review panels
- Immunology (5)
Most recent Wieslab AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981750 | WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM | MOB | 1998-07-22 | 65 |
| K981748 | WIELISA ANCA SCREENING KIT TEST SYSTEM | MOB | 1998-07-22 | 65 |
| K974169 | WIELISA ANTI-GBM TEST SYSTEM | DBL | 1998-02-17 | 104 |
| K974167 | WIELISA PR-3 ANCA TEST SYSTEM | MOB | 1998-02-17 | 104 |
| K974166 | WIELISA MPO ANCA TEST SYSTEM | MOB | 1998-02-17 | 104 |
Recalls
openFDA lists no recalls under a recalling firm named Wieslab AB.
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 Wieslab AB?
FDA lists 5 510(k) clearances under the applicant name “Wieslab AB” (first 1998, latest 1998), 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 Wieslab AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wieslab AB is 104 days.
Which FDA product codes appear under Wieslab AB?
The most frequent FDA product codes under this applicant name are MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca), 4); DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, 1).
Next steps
- See all 5 Wieslab AB clearances with predicates and recalls
- Run predicate analysis for product code MOB, Wieslab AB'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.