Atellica IM Total hCG (ThCG)

Atellica IM Total hCG (ThCG) is an FDA 510(k)-cleared medical device (K172322) 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 March 28, 2018. Regulation: 8.