AMYLASE SR LIQUID STABLE REAGENT SET

AMYLASE SR LIQUID STABLE REAGENT SET is an FDA 510(k)-cleared medical device (K862733) manufactured by Medical Analysis Systems, 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 September 28, 1986. Regulation: 8.