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510(k) K200279

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine by Phadia AB — Product Code DHB

K200279 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine". The FDA issued a decision of Substantially Equivalent on May 1, 2020. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Phadia AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2020
Date Received
February 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Device Class
Class II
Regulation Number
866.5750
Review Panel
IM
Submission Type

Other clearances by Phadia AB

  • K253367 — EliA CTD 13 Screen (June 25, 2026)
  • K212181 — ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Alle (August 3, 2022)
  • K210902 — EliA Ro52, EliA Ro60 (July 27, 2022)
  • K202540 — EliA Rib-P (September 13, 2021)
  • K202541 — EliA RNA Pol III (September 13, 2021)
  • K202067 — EliA SmDP-S (July 14, 2021)
  • K190710 — EliA SymphonyS Immunoassay (November 29, 2019)
  • K190315 — ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e23 (May 14, 2019)
  • K181871 — EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG (March 1, 2019)
  • K183007 — EliA SmDP Immunoassay (December 24, 2018)

Other clearances for product code DHB

  • K260280 — NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Cap (June 18, 2026)
  • K260059 — NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excel (May 15, 2026)
  • K252775 — NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Cap (January 16, 2026)
  • K252493 — NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture (December 23, 2025)
  • K242531 — NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum h (April 23, 2025)
  • K212181 — ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Alle (August 3, 2022)
  • K220162 — Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, (February 18, 2022)
  • K193613 — Allergen-Specific IgE Assay 12 Allergen Bundle (October 18, 2021)
  • K200825 — NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; (June 26, 2020)
  • K191510 — Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, (July 31, 2019)

FDA data resources