510(k) K230863

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit by Zeus Scientific — Product Code LSR

K230863 is an FDA 510(k) premarket notification submitted by Zeus Scientific for the device "ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit". The FDA issued a decision of Substantially Equivalent on July 13, 2023. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Zeus Scientific has at least 10 other 510(k) clearances on record.