K260591

NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut

510(k) number: K260591
Device name: NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut
Applicant: Hycor Biomedical CA · US
Product code: DHB — System, Test, Radioallergosorbent (Rast) Immunologic
Decision date: 2026-07-21
Date received: 2026-02-23
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: K260591.pdf

Official FDA record: K260591

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