510(k) K150854

ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut by Phadia AB — Product Code DHB

K150854 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut". The FDA issued a decision of Substantially Equivalent on December 14, 2015. 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.