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Alfa Wassermann
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ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT is an FDA 510(k)-cleared medical device (K113436) manufactured by Alfa Wassermann. 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 July 11, 2012. Regulation: 8.