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) 号: K261027
器械名称: 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
申请人: Hycor Biomedical CA · US
产品代码: DHB — System, Test, Radioallergosorbent (Rast) Immunologic
批准日期: 2026-07-24
受理日期: 2026-03-30
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Immunology

510(k) Summary（FDA 官方 PDF）： K261027.pdf

FDA 官方记录： K261027

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。