LOCI Total Vitamin D Total Assay, LOCI VITD CAL

LOCI Total Vitamin D Total Assay, LOCI VITD CAL is an FDA 510(k)-cleared medical device (K162298) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 2017. Regulation: 8.