ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS

ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS is an FDA 510(k)-cleared medical device (K080167) 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 August 7, 2008. Regulation: 8.