
Chiron Diagnostics Corp.
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ACS:CENTAUR PSA2 IMMUNOASSAY is an FDA 510(k)-cleared medical device (K981839) 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 August 11, 1998. Regulation: 8.