
Chiron Diagnostics Corp.
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CHIRON DIAGNOSTICS ACS:180TU P is an FDA 510(k)-cleared medical device (K970539) manufactured by Chiron Diagnostics Corp.. 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 March 23, 1997. Regulation: 8.