
Miles, Inc.
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DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS is an FDA 510(k)-cleared medical device (K933682) manufactured by Miles, 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 11, 1994. Regulation: 8.