Aesku Diagnostics: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Aesku Diagnostics” (first 2004, latest 2013), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 153 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 | 1 | 206 |
| 2013 | 1 | 153 |
| 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 |
|---|---|---|---|
| LSW | Anti-Dna Antibody, Antigen And Control | 2 | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | 2 |
| MST | Antibodies, Gliadin | 2 | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 | 1 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 1 | 1 |
Review panels
- Immunology (9)
Most recent Aesku Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | MST | 2013-12-05 | 153 |
| K120889 | AESKUSLIDES ANA HEP-2 | DHN | 2012-10-15 | 206 |
| K091859 | AESKU PR3 | MOB | 2010-06-03 | 349 |
| K091860 | AESKULISA MPO, MODEL 30-7303US | MOB | 2010-02-23 | 249 |
| K081251 | MODIFICATION TO AESKULISA DS DNA G | LSW | 2008-05-13 | 11 |
| K081104 | AESKULISA ANA HEP-2, REF 30-7115US | LKJ | 2008-05-02 | 14 |
| K052439 | AESKULISA GLIA A AND AESKULISA GLIA G | MST | 2006-02-07 | 154 |
| K041628 | AESKULISA DS DNA G | LSW | 2004-10-14 | 120 |
| K041753 | AESKULISA ENA 6 S | LLL | 2004-07-14 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Aesku Diagnostics.
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.
- Aesku, Inc. (6 510(k)s)
- Aesku.Diagnostics GmbH & Co. KG (2 510(k)s)
- Aesku Systems GmbH&Co.Kg (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aesku Diagnostics?
FDA lists 9 510(k) clearances under the applicant name “Aesku Diagnostics” (first 2004, latest 2013), across 6 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 Aesku Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aesku Diagnostics is 153 days.
Which FDA product codes appear under Aesku Diagnostics?
The most frequent FDA product codes under this applicant name are LSW (Anti-Dna Antibody, Antigen And Control, 2); MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca), 2); MST (Antibodies, Gliadin, 2).
Next steps
- See all 9 Aesku Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code LSW, Aesku Diagnostics'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.