Atellica CH Amylase_2 (AMY_2)

Atellica CH Amylase_2 (AMY_2) is an FDA 510(k)-cleared medical device (K191454) 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 July 29, 2019. Regulation: 8.