510(k) K113847

BORRELIA BURGDORFERI IGG BLOT TEST by Gold Standard Diagnostics — Product Code LSR

K113847 is an FDA 510(k) premarket notification submitted by Gold Standard Diagnostics for the device "BORRELIA BURGDORFERI IGG BLOT TEST". The FDA issued a decision of Substantially Equivalent on April 11, 2012. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Gold Standard Diagnostics has at least 10 other 510(k) clearances on record.