ADVIA Centaur TSH3-Ultra

ADVIA Centaur TSH3-Ultra is an FDA 510(k)-cleared medical device (K150403) 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 30, 2015. Regulation: 8.