Euro-Diagnostica AB: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Euro-Diagnostica AB” (first 1997, latest 2010), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 175 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 |
|---|---|---|---|
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 3 | 3 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | 2 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
Review panels
- Immunology (6)
Most recent Euro-Diagnostica AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093908 | CCPOINT | NHX | 2010-12-01 | 344 |
| K091657 | IMMUNOSCAN CCPLUS | NHX | 2009-11-19 | 163 |
| K062045 | EDIA ANTI-CCP | NHX | 2006-12-04 | 138 |
| K971690 | IMMUNOSCAN PR3-ANCA | MOB | 1997-10-29 | 175 |
| K971689 | IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT | MOB | 1997-10-29 | 175 |
| K971464 | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT | DBL | 1997-10-29 | 190 |
Recalls
openFDA lists no recalls under a recalling firm named Euro-Diagnostica 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 Euro-Diagnostica AB?
FDA lists 6 510(k) clearances under the applicant name “Euro-Diagnostica AB” (first 1997, latest 2010), across 3 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 Euro-Diagnostica AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Euro-Diagnostica AB is 175 days.
Which FDA product codes appear under Euro-Diagnostica AB?
The most frequent FDA product codes under this applicant name are NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp), 3); MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca), 2); DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, 1).
Next steps
- See all 6 Euro-Diagnostica AB clearances with predicates and recalls
- Run predicate analysis for product code NHX, Euro-Diagnostica 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.