510(k) K033802

ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM by Zeus Scientific, Inc. — Product Code DHR

K033802 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on February 27, 2004. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.