ADVIA CENTAUR TSH3-ULTRA METHOD

ADVIA CENTAUR TSH3-ULTRA METHOD is an FDA 510(k)-cleared medical device (K083844) manufactured by Siemens Healthcare Diagnostics. 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 May 7, 2009. Regulation: 8.