
Em Diagnostic Systems, Inc.
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EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 is an FDA 510(k)-cleared medical device (K873426) 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 October 28, 1987. Regulation: 8.