SYSTEMATE A AMYLASE HEM 67204

SYSTEMATE A AMYLASE HEM 67204 is an FDA 510(k)-cleared medical device (K843645) manufactured by Em Diagnostic 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 27, 1984. Regulation: 8.