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

Phadia AB — Predicate Candidate Screening

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

232 daysmedian FDA review time

376 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253367	EliA CTD 13 Screen	Phadia AB	2026-06-25	268	0
K212181	ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, W	Phadia AB	2022-08-03	386	0
K210902	EliA Ro52, EliA Ro60	Phadia AB	2022-07-27	488	0
K202540	EliA Rib-P	Phadia AB	2021-09-13	376	0
K202541	EliA RNA Pol III	Phadia AB	2021-09-13	376	0
K202067	EliA SmDP-S	Phadia AB	2021-07-14	352	0
K200279	ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-	Phadia AB	2020-05-01	87	0
K190710	EliA SymphonyS Immunoassay	Phadia AB	2019-11-29	255	0
K190315	ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, Im	Phadia AB	2019-05-14	90	0
K181871	EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay	Phadia AB	2019-03-01	232	0
K183007	EliA SmDP Immunoassay	Phadia AB	2018-12-24	54	0
K182747	EliA RF IgM Immunoassay	Phadia AB	2018-12-18	81	0
K182353	EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Im	Phadia AB	2018-11-27	90	0
K181556	EliA M2 Immunoassay	Phadia AB	2018-07-13	30	0
K181329	EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA	Phadia AB	2018-06-25	38	0
K173726	ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Co	Phadia AB	2018-04-16	132	0
K173792	EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immun	Phadia AB	2018-03-13	89	1
K173704	ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCA	Phadia AB	2018-03-02	88	0
K163370	ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific Ig	Phadia AB	2017-05-05	155	0
K161899	ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control	Phadia AB	2016-07-28	17	0
K151799	EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Th	Phadia AB	2016-03-25	267	0
K150597	ImmunoCAP Allergen d202, Allergen component rDer p 1,House d	Phadia AB	2016-02-29	357	0
K151029	Phadia Prime	Phadia AB	2016-01-19	277	0
K150854	ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; I	Phadia AB	2015-12-14	258	0
K133404	IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE	Phadia AB	2014-02-24	110	1
K131738	IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CON	Phadia AB	2013-07-10	27	1
K123275	IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AN	Phadia AB	2013-06-28	252	1
K121156	AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF	Phadia AB	2013-03-13	331	1
K101251	IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE	Phadia AB	2011-05-27	388	0
K100999	IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01	Phadia AB	2010-12-15	247	0
K092050	IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01	Phadia AB	2009-11-20	136	0
K081830	IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, I	Phadia AB	2009-03-16	259	0
K071913	IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01	Phadia AB	2007-08-24	44	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