K261027

NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut

510(k) number: K261027
Device name: NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut
Applicant: Hycor Biomedical CA · US
Product code: DHB — System, Test, Radioallergosorbent (Rast) Immunologic
Decision date: 2026-07-24
Date received: 2026-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Immunology

PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain

Also available from FDA: K261027.pdf

Official FDA record: K261027

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.