
Hitachi Chemical Diagnostics, Inc.
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AP 72OS SEMI-AUTOMATED INSTRUMENT is an FDA 510(k)-cleared medical device (K112910) manufactured by Hitachi Chemical Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 19, 2012. Regulation: 8.