510(k) K220162

Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria by Hycor Biomedical — Product Code DHB

K220162 is an FDA 510(k) premarket notification submitted by Hycor Biomedical for the device "Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria". The FDA issued a decision of Substantially Equivalent on February 18, 2022. 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.