ACE AMYLASE REAGENT

ACE AMYLASE REAGENT is an FDA 510(k)-cleared medical device (K951548) manufactured by Schiapparelli Biosystems, 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 May 14, 1995. Regulation: 8.