510(k) K113397

ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM by Zeus Scientific, Inc. — Product Code LSR

K113397 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 26, 2012. 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.