510(k) K150597

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite by Phadia AB — Product Code DHB

K150597 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite". The FDA issued a decision of Substantially Equivalent on February 29, 2016. 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.