Atellica IM Folate Assay

Atellica IM Folate Assay is an FDA 510(k)-cleared medical device (K172201) manufactured by Siemens Healthcare Diagnostics, Inc.. 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 April 11, 2018. Regulation: 8.