510(k) K173726

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut by Phadia AB — Product Code DHB

K173726 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut". The FDA issued a decision of Substantially Equivalent on April 16, 2018. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Phadia AB has at least 10 other 510(k) clearances on record.