Phadia AB - FDA 510(k) Cleared Devices
Recent clearances: 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, EliA Rib-P
32
Total
32
Cleared
0
Denied
FDA 510(k) Regulatory Record - Phadia AB Immunology ✕
32 devices
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
EliA Rib-P
Immunology
376d
Cleared
Sep 13, 2021
EliA RNA Pol III
Immunology
376d
Cleared
Jul 14, 2021
EliA SmDP-S
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
Cleared
Nov 27, 2018
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
Immunology
90d