EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019

EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 is an FDA 510(k)-cleared medical device (K874705) manufactured by Em Diagnostic Systems, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 1987. Regulation: 8.