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Hitachi Chemical Diagnostics, Inc.
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HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) is an FDA 510(k)-cleared medical device (K113809) 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 August 16, 2012. Regulation: 8.