510(k) K043460

OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 by Olympus America, Inc. — Product Code JIX

K043460 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071". The FDA issued a decision of Substantially Equivalent on January 31, 2005. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Olympus America, Inc. has at least 10 other 510(k) clearances on record.