510(k) K991179

ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM by Zeus Scientific, Inc. — Product Code DDC

K991179 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 17, 1999. The device falls under product code DDC (Thyroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5870. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.