510(k) Report

FDA applicant

Phadia US, Inc.

Portage, MI22 decisions2006–20157 recalls

FDA records 22 decisions for Phadia US, Inc. (Portage, MI) from 2006 to 2015: 21 510(k) clearances and 1 De Novo grant. Most are in product codes DHB (System, Test, Radioallergosorbent (Rast)…) and MID (System, Test, Anticardiolipin Immunological). Its devices cite 40 predicates, 0 of them its own earlier devices. 7 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Phadia US, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 32008: 12009: 32010: 32011: 22012: 32013: 22014: 22015: 1
2007high 3 (2007) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

3in 2023

2014: 12015: 12019: 12020: 12023: 3
2007high 3 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Phadia US, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Phadia US, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DHBSystem, Test, Radioallergosorbent (Rast) Immunological4decisions
  • MIDSystem, Test, Anticardiolipin Immunological2decisions
  • MVMAutoantibodies, Endomysial (Tissue Transglutaminase)2decisions
  • MSTAntibodies, Gliadin2decisions
  • LKPAnti-Sm Antibody, Antigen And Control1decision
  • LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls1decision

Also: LLL (1), DBM (1), MSV (1), LKO (1), JNL (1), LKJ (1).

Whose devices does it build on?

Its devices cite 40 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K132631Eia SMDP ImmunoassayPhadia US, Inc. · 20142cite it
  • DEN120001Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve Control Strip…Phadia US, Inc. · 20122cite it
  • K131821Elia (TM) Cardiolipin Iga ImmunoassayPhadia US, Inc. · 20131cites it
  • K062583Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01Phadia US, Inc. · 20061cites it
  • K072149Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01Phadia US, Inc. · 20081cites it
  • K141375Elia M2; Immunoassay, Positive Control 100, Positive Control 250Phadia US, Inc. · 20151cites it

What has FDA decided for it lately?

  • K141375Elia M2; Immunoassay, Positive Control 100, Positive Control 250Phadia US, Inc. · 2015
  • K140225Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/GBM Positive Control 100, Elia…Phadia US, Inc. · 20141 recall
  • K132631Eia SMDP ImmunoassayPhadia US, Inc. · 20141 recall
  • K131821Elia (TM) Cardiolipin Iga ImmunoassayPhadia US, Inc. · 2013
  • K122197Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige AntibodiesPhadia US, Inc. · 20131 recall
  • K113841Immunocap Allergen Components BundlePhadia US, Inc. · 2012
  • K112414Elia B2-Glycoprotein I Iga ImmunoassayPhadia US, Inc. · 2012
  • DEN120001Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve Control Strip…Phadia US, Inc. · 2012

All 22 as Phadia US, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K140225EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro…May 24, 2023Class II
  • K093459Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG…May 1, 2023Class II
  • K093459EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA…May 1, 2023Class II
  • K072393EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of…Dec 14, 2020Class II
  • K102673EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the…May 10, 2019Class II
  • K132631EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the…Dec 28, 2015Class II

Other applicant names beginning “Phadia”

FDA records each applicant name separately; these may or may not be the same firm.

Phadia AB 34