510(k) K163370

ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE by Phadia AB — Product Code DHB

K163370 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE". The FDA issued a decision of Substantially Equivalent on May 5, 2017. 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.