510(k) K191398

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System by Zeus Scientific, Inc. — Product Code LSR

K191398 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System". The FDA issued a decision of Substantially Equivalent on July 29, 2019. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.