510(k) K191510

Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae by Hycor Biomedical — Product Code DHB

K191510 is an FDA 510(k) premarket notification submitted by Hycor Biomedical for the device "Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae". The FDA issued a decision of Substantially Equivalent on July 31, 2019. 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.