Medical Device Manufacturer · SE , Uppsala

Phadia AB - FDA 510(k) Cleared Devices

33 submissions · 33 cleared · Since 2007

Recent clearances: EliA CTD 13 Screen, ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed, EliA Ro52, EliA Ro60

View 33 510(k) Devices ↓ Official Website

33

Total

33

Cleared

0

Denied

FDA 510(k) Regulatory Record - Phadia AB Immunology ✕

33 devices

1-12 of 33

Cleared Jun 25, 2026

EliA CTD 13 Screen

Immunology · 268d

Cleared Aug 03, 2022

ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP...

Immunology · 386d

Cleared Jul 27, 2022

EliA Ro52, EliA Ro60

Immunology · 488d

Cleared Sep 13, 2021

Immunology · 376d

Cleared Sep 13, 2021

EliA RNA Pol III

Immunology · 376d

Cleared Jul 14, 2021

Immunology · 352d

Cleared May 01, 2020

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal)...

Immunology · 87d

Cleared Nov 29, 2019

EliA SymphonyS Immunoassay

Immunology · 255d

Cleared May 14, 2019

ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen...

Immunology · 90d

Cleared Mar 01, 2019

EliA Celikey IgG Immunoassay

Immunology · 232d

Cleared Dec 24, 2018

EliA SmDP Immunoassay

Immunology · 54d

Cleared Dec 18, 2018

EliA RF IgM Immunoassay

Immunology · 81d