
Em Diagnostic Systems, Inc.
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EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 is an FDA 510(k)-cleared medical device (K881607) manufactured by Em Diagnostic Systems, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 31, 1988. Regulation: 8.