Device Listing 1237003276

Listing Summary#

Listing key
1237003276
Premarket submission
K260280
Device
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
Product code
DHB
Decision date
2026-06-18