Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Euroimmun Us, Inc. — Predicate Candidate Screening

19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

268 daysmedian FDA review time

363 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K193115	EUROIMMUN Anti-BP230-CF ELISA (IgG)	Euroimmun Us, Inc.	2020-09-17	310
K183313	EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMU	Euroimmun Us, Inc.	2019-02-28	91
K172582	EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN	Euroimmun Us, Inc.	2018-05-24	269
K172252	EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUR	Euroimmun Us, Inc.	2018-04-20	268
K172244	EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern	Euroimmun Us, Inc.	2018-04-20	268
K172722	Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)	Euroimmun Us, Inc.	2017-12-10	90
K153308	EUROIMMUN Anti-West Nile Virus ELISA (IgM)	Euroimmun Us, Inc.	2016-08-12	269
K153303	EUROIMMUN Anti-West Nile Virus ELISA (IgG)	Euroimmun Us, Inc.	2016-08-10	268
K141827	EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFT	Euroimmun Us, Inc.	2015-04-17	284
K132195	EUROIMMUN ANTI-PLA2R ELISA (IGG)	Euroimmun Us, Inc.	2014-06-27	347
K100017	EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOC	Euroimmun Us, Inc.	2010-09-13	252
K091969	EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESM	Euroimmun Us, Inc.	2010-09-02	428
K092736	EUROIMMUN ANTI-M2-3E ELISA (IGG)	Euroimmun Us, Inc.	2010-09-02	363
K083053	EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)	Euroimmun Us, Inc.	2009-08-07	297
K083052	EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)	Euroimmun Us, Inc.	2009-07-28	287
K083850	EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST	Euroimmun Us, Inc.	2009-05-20	147
K083381	EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)	Euroimmun Us, Inc.	2009-04-15	152
K082130	EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)	Euroimmun Us, Inc.	2009-04-07	252
K083615	EUROIMMUN ANTI BP 180-4X ELISA (IGG)	Euroimmun Us, Inc.	2009-03-16	98

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