510(k) K003721

MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER by Olympus America, Inc. — Product Code JJE

K003721 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on December 18, 2000. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Olympus America, Inc. has at least 10 other 510(k) clearances on record.