Device Listing 1896965245

Listing Summary#

Listing key
1896965245
Premarket submission
K261027
Device
NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut
Applicant
Hycor Biomedical
Product code
DHB
Decision date
2026-07-24