510(k) K063186

ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM by Zeus Scientific, Inc. — Product Code LFX

K063186 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on March 21, 2007. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.