Device Listing 1019395140

Listing Summary#

Listing key
1019395140
Premarket submission
K260591
Device
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
Product code
DHB
Decision date
2026-07-21