510(k) K983422

THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET by Zeus Scientific, Inc. — Product Code LRM

K983422 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET". The FDA issued a decision of Substantially Equivalent on November 18, 1998. The device falls under product code LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.