510(k) K200023

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit by Gold Standard Diagnostics — Product Code LSR

K200023 is an FDA 510(k) premarket notification submitted by Gold Standard Diagnostics for the device "Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit". The FDA issued a decision of Substantially Equivalent on April 6, 2020. 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.