510(k) K182479

NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus by Hycor Biomedical — Product Code DHB

K182479 is an FDA 510(k) premarket notification submitted by Hycor Biomedical for the device "NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus". The FDA issued a decision of Substantially Equivalent on December 4, 2018. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Hycor Biomedical has at least 10 other 510(k) clearances on record.