CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY

CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY is an FDA 510(k)-cleared medical device (K982680) manufactured by Chiron Diagnostics Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 14, 1998. Regulation: 8.