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) number: K260280
Device name: 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
Applicant: Hycor Biomedical CA · US
Product code: DHB — System, Test, Radioallergosorbent (Rast) Immunologic
Decision date: 2026-06-18
Date received: 2026-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Immunology

PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K260280.pdf

Official FDA record: K260280

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