K260059

NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)

510(k) number: K260059
Device name: NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)
Applicant: Hycor Biomedical CA · US
Product code: DHB — System, Test, Radioallergosorbent (Rast) Immunologic
Decision date: 2026-05-15
Date received: 2026-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Immunology

PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain

Also available from FDA: K260059.pdf

Official FDA record: K260059

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