510(k) Report

FDA applicant

Phadia AB

Uppsala, SE34 decisions2007–20265 recalls

FDA records 34 decisions for Phadia AB (Uppsala, SE) from 2007 to 2026: 34 510(k) clearances. Most are in product codes DHB (System, Test, Radioallergosorbent (Rast)…) and DGC (Ige, Antigen, Antiserum, Control). Its devices cite 53 predicates, 5 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Phadia GmbH”.

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 AB’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2007: 12009: 22010: 12011: 12013: 32014: 22015: 12016: 42017: 12018: 82019: 32020: 12021: 32022: 22026 (partial year): 1
2007high 8 (2018) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2023

2014: 12017: 22019: 12023: 1
2007high 2 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Phadia AB’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) Immunological16decisions
  • DGCIge, Antigen, Antiserum, Control2decisions
  • LLLExtractable Antinuclear Antibody, Antigen And Control2decisions
  • LKPAnti-Sm Antibody, Antigen And Control2decisions
  • LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls2decisions
  • OYLTryptase Assay System1decision

Also: MSV (1), DBM (1), MQA (1), DHR (1), NYO (1), MOB (1).

Whose devices does it build on?

Its devices cite 53 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K101251Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap Allergen D203, AllergenPhadia AB · 20111cites it
  • K133404Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMHPhadia AB · 20141cites it
  • K202540EliA Rib-PPhadia AB · 20211cites it
  • K202541EliA RNA Pol IIIPhadia AB · 20211cites it
  • K081830Immunocap Rapid Inhalant Profile , Immunocap Rapid Reader, Immunocap Rapid Reader Check Device, and…Phadia AB · 20091cites it
  • K190710EliA SymphonyS ImmunoassayPhadia AB · 20191cites it

What has FDA decided for it lately?

  • K253367EliA CTD 13 ScreenPhadia AB · 2026
  • K212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen…Phadia AB · 2022
  • K210902EliA Ro52, EliA Ro60Phadia AB · 2022
  • K202540EliA Rib-PPhadia AB · 2021
  • K202541EliA RNA Pol IIIPhadia AB · 2021
  • K202067EliA SmDP-SPhadia AB · 2021
  • K200279ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovinePhadia AB · 2020
  • K190710EliA SymphonyS ImmunoassayPhadia AB · 2019

All 33 as Phadia AB →The one decision as Phadia GmbH →

What has been recalled?

5 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
  • K102673EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the…May 10, 2019Class II
  • K151029Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia…Nov 20, 2017Class II
  • K133404Phadia 1000 Instrument, Article Number 12-3800-01.Jul 5, 2017Class II
  • K121156Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All…Nov 20, 2014Class II

Other applicant names beginning “Phadia”

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

Phadia US, Inc. 22