510(k) K210901

Elecsys Vitamin D total III by Roche Diagnostics — Product Code MRG

K210901 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Vitamin D total III". The FDA issued a decision of Substantially Equivalent on September 1, 2021. 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.