510(k) K063144

VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM by Ortho-Clinical Diagnostics, Inc. — Product Code JJE

K063144 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 13, 2006. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.