510(k) K981743

OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER by Olympus America, Inc. — Product Code CKB

K981743 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on June 9, 1998. The device falls under product code CKB (Acid Phosphatase, Naphthyl Phosphate), a Class II device regulated under 21 CFR 862.1020. Olympus America, Inc. has at least 10 other 510(k) clearances on record.