510(k) K162840

Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 by Roche Diagnostics — Product Code MRG

K162840 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5". The FDA issued a decision of Substantially Equivalent on February 8, 2017. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Roche Diagnostics has at least 10 other 510(k) clearances on record.