K260280

NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg

510(k) 号: K260280
器械名称: NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg
申请人: Hycor Biomedical CA · US
产品代码: DHB — System, Test, Radioallergosorbent (Rast) Immunologic
批准日期: 2026-06-18
受理日期: 2026-01-29
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Immunology

PDF下载 510(k) Summary本站存档 · 0.7 MB · FDA 公有领域文件

也可从 FDA 官方下载： K260280.pdf

FDA 官方记录： K260280

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。