510(k) K100728

ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM by Zeus Scientific, Inc. — Product Code LSR

K100728 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 6, 2010. 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.