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

Euro-Diagnostica AB — Predicate Candidate Screening

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

175 daysmedian FDA review time

344 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K093908	CCPOINT	Euro-Diagnostica AB	2010-12-01	344	0
K091657	IMMUNOSCAN CCPLUS	Euro-Diagnostica AB	2009-11-19	163	1
K062045	EDIA ANTI-CCP	Euro-Diagnostica AB	2006-12-04	138	0
K971690	IMMUNOSCAN PR3-ANCA	Euro-Diagnostica AB	1997-10-29	175	0
K971464	IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT	Euro-Diagnostica AB	1997-10-29	190	0
K971689	IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTI	Euro-Diagnostica AB	1997-10-29	175	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