510(k) K161140

VITROS Chemistry Products Calibrator Kit 3 by Ortho-Clinical Diagnostics, Inc. — Product Code JIX

K161140 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS Chemistry Products Calibrator Kit 3". The FDA issued a decision of Substantially Equivalent on May 20, 2016. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.