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U.S. Army Medical Research Institute of Infectious
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SMART LEISH, MODEL LGM1-050 is an FDA 510(k)-cleared medical device (K081868) manufactured by U.S. Army Medical Research Institute of Infectious. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 24, 2011. Regulation: 8.