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

Phadia US, Inc. — Predicate Candidate Screening

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

200 daysmedian FDA review time

372 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K141375	ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL	Phadia US, Inc.	2015-02-13	262	0
K140225	ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUN	Phadia US, Inc.	2014-10-27	271	1
K132631	EIA SMDP IMMUNOASSAY	Phadia US, Inc.	2014-08-29	372	1
K131821	ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY	Phadia US, Inc.	2013-12-23	186	0
K122197	AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF	Phadia US, Inc.	2013-08-28	400	1
K113841	IMMUNOCAP ALLERGEN COMPONENTS BUNDLE	Phadia US, Inc.	2012-09-13	260	0
K112414	ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY	Phadia US, Inc.	2012-06-22	305	0
DEN120001	IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50	Phadia US, Inc.	2012-02-15	34	0
K111919	IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONEN	Phadia US, Inc.	2011-12-22	168	0
K102673	RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM	Phadia US, Inc.	2011-09-30	379	0
K093459	ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMU	Phadia US, Inc.	2010-08-13	280	2
K091845	CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM	Phadia US, Inc.	2010-06-07	350	0
K092978	IMMUNOCAP RAPID READER, MODEL 12-3600-10	Phadia US, Inc.	2010-01-19	113	0
K083117	ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-	Phadia US, Inc.	2009-05-28	218	0
K082759	ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUN	Phadia US, Inc.	2009-04-10	200	0
K083188	VARELISA RECOMBI ANA SCREEN, MODEL 12 596	Phadia US, Inc.	2009-03-13	135	0
K072149	ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83	Phadia US, Inc.	2008-01-15	165	0
K072393	ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL,	Phadia US, Inc.	2007-12-07	102	1
K072661	IMMUNOCAP THYRLOBULIN IMMUNOCAP	Phadia US, Inc.	2007-11-20	60	0
K063775	ELIA GLIADIN IGA, IGG AND CELIAC CONTROL	Phadia US, Inc.	2007-03-14	83	0
K062787	ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL	Phadia US, Inc.	2006-12-29	102	0
K062583	ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL	Phadia US, Inc.	2006-12-26	116	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