Euroimmun Us, Inc.: FDA clearances and approvals
Euroimmun Us, Inc. has 36 FDA 510(k) clearances (first 2006, latest 2020), plus 1 De Novo decision, across 21 product codes in 3 review panels. Median 510(k) review time: 268 days. Since 2017 its median was 268 days, against 167 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 406 |
| 2013 | 5 | 237 |
| 2014 | 3 | 314 |
| 2015 | 2 | 282 |
| 2016 | 3 | 268 |
| 2017 | 1 | 90 |
| 2018 | 3 | 268 |
| 2019 | 1 | 91 |
| 2020 | 1 | 310 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Euroimmun Us, Inc.'s cleared 510(k)s took a median 268 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 167 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 5 | 5 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 3 | 3 |
| LSR | Reagent, Borrelia Serological Reagent | 3 | 3 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 2 | 2 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 2 | 2 |
| MST | Antibodies, Gliadin | 2 | 2 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | 2 |
| NIY | Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis | 2 | 2 |
| NOP | Elisa, Antibody, West Nile Virus | 2 | 2 |
| OEG | Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 | 2 | 2 |
Plus 11 more product codes.
Review panels
- Immunology (30)
- Microbiology (6)
- Clinical Chemistry (1)
Most recent Euroimmun Us, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG) | OEG | 2020-09-17 | 310 |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) | MVM | 2019-02-28 | 91 |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern | MOB | 2018-05-24 | 269 |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | KTL | 2018-04-20 | 268 |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | KTL | 2018-04-20 | 268 |
| K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | LSR | 2017-12-10 | 90 |
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG) | LSR | 2016-08-25 | 84 |
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | NOP | 2016-08-12 | 269 |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | NOP | 2016-08-10 | 268 |
| K142038 | EUROIMMUN LYME ELISA(IgG/IgM) | LSR | 2015-05-04 | 280 |
26 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140002 | De Novo | Anti-Phospholipase A2 Receptor | 2014-05-29 |
Recalls
openFDA lists no recalls under a recalling firm named Euroimmun Us, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Euroimmun Us, Inc. have?
Euroimmun Us, Inc. has 36 FDA 510(k) clearances (first 2006, latest 2020), plus 1 De Novo decision, across 21 product codes in 3 review panels.
How long does FDA take to clear Euroimmun Us, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Euroimmun Us, Inc.'s cleared 510(k)s is 268 days. Since 2017: 268 days, versus 167 days for all cleared 510(k)s in the same product codes.
What devices does Euroimmun Us, Inc. make?
Its most frequent FDA product codes are MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca), 5); DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 3); LSR (Reagent, Borrelia Serological Reagent, 3).
Has Euroimmun Us, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Euroimmun Us, Inc. Related entities may recall under other names.
Next steps
- See all 36 Euroimmun Us, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MOB, Euroimmun Us, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.