510(k) K162298

LOCI Total Vitamin D Total Assay, LOCI VITD CAL by Siemens Healthcare Diagnostics — Product Code MRG

K162298 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "LOCI Total Vitamin D Total Assay, LOCI VITD CAL". The FDA issued a decision of Substantially Equivalent on March 16, 2017. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.