Atellica CH Enzymatic Creatinine_3 (ECre3)

Atellica CH Enzymatic Creatinine_3 (ECre3) is an FDA 510(k)-cleared medical device (K212223) 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 November 23, 2021. Regulation: 8.