510(k) K000363

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

K000363 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on February 18, 2000. 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.