510(k) K984153

THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. by Zeus Scientific, Inc. — Product Code LJZ

K984153 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.". The FDA issued a decision of Substantially Equivalent on January 11, 1999. The device falls under product code LJZ (Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.