Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Euroimmun US — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
280 daysmedian FDA review time
508 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG) | Euroimmun US | 2016-08-25 | 84 | 0 |
| K142038 | EUROIMMUN LYME ELISA(IgG/IgM) | Euroimmun US | 2015-05-04 | 280 | 0 |
| K140224 | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) | Euroimmun US | 2014-12-09 | 314 | 0 |
| DEN140002 | EUROIMMUN ANTI-PLA2R IFA | Euroimmun US | 2014-05-29 | 62 | 0 |
| K131791 | IFA 40: HEP-20-10 | Euroimmun US | 2014-02-26 | 253 | 0 |
| K123660 | 25-OH VITAMIN D ELISA | Euroimmun US | 2013-07-17 | 231 | 0 |
| K131185 | ANA SCREEN ELISA (IGG) | Euroimmun US | 2013-07-15 | 80 | 0 |
| K123261 | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) | Euroimmun US | 2013-06-12 | 237 | 0 |
| K113439 | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG | Euroimmun US | 2013-04-12 | 508 | 0 |
| K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | Euroimmun US | 2013-04-09 | 550 | 0 |
| K112223 | EUROIMMUN ANTI-LKM-1 ELISA(LGG) | Euroimmun US | 2012-09-11 | 406 | 0 |
| K112221 | EUROIMMUN ANTI-SLA/LP ELISA(LGG) | Euroimmun US | 2012-09-11 | 406 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda