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Hitachi Chemical Diagnostics, Inc.
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HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST is an FDA 510(k)-cleared medical device (K120945) manufactured by Hitachi Chemical Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 6, 2013. Regulation: 8.