ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE

ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE is an FDA 510(k)-cleared medical device (K123018) manufactured by Alfa Wassermann Diagnostic Technologies, Inc.. 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 April 22, 2013. Regulation: 8.