Sweden Diagnostics (Germany) GmbH: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Sweden Diagnostics (Germany) GmbH” (first 2004, latest 2005), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | 2 |
| MST | Antibodies, Gliadin | 2 | 2 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | 2 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 | 1 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 1 | 1 |
Review panels
- Immunology (8)
Most recent Sweden Diagnostics (Germany) GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050967 | VARELISA RECOMBI CTD SCREEN, MODEL 13096 | LJM | 2005-06-28 | 71 |
| K050625 | VARELISA RECOMBI ANA PROFILE, MODEL 18496 | LJM | 2005-04-26 | 46 |
| K042629 | VARELISA SM ANTIBODIES, MODEL 18296 | LKP | 2004-12-08 | 72 |
| K041357 | VARELISA GLIADIN IGG ANTIBODIES | MST | 2004-08-02 | 74 |
| K041173 | CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 | MVM | 2004-08-02 | 89 |
| K041174 | CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 | MVM | 2004-07-19 | 75 |
| K041354 | VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 | MST | 2004-07-16 | 57 |
| K041040 | VARELISA MPO ANCA, MODEL 17648/17696 | MOB | 2004-06-16 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Sweden Diagnostics (Germany) GmbH.
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.
- Sweden & Martina S.P.A. (8 510(k)s)
- Sweden Diagnostics (Us), Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sweden Diagnostics (Germany) GmbH?
FDA lists 8 510(k) clearances under the applicant name “Sweden Diagnostics (Germany) GmbH” (first 2004, latest 2005), across 5 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 Sweden Diagnostics (Germany) GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sweden Diagnostics (Germany) GmbH is 72 days.
Which FDA product codes appear under Sweden Diagnostics (Germany) GmbH?
The most frequent FDA product codes under this applicant name are LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 2); MST (Antibodies, Gliadin, 2); MVM (Autoantibodies, Endomysial(Tissue Transglutaminase), 2).
Next steps
- See all 8 Sweden Diagnostics (Germany) GmbH clearances with predicates and recalls
- Run predicate analysis for product code LJM, Sweden Diagnostics (Germany) GmbH'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.