ALIMENTERICS LARA (TM) BREATH TEST SYSTEM

ALIMENTERICS LARA (TM) BREATH TEST SYSTEM is an FDA 510(k)-cleared medical device (K973000) manufactured by Alimenterics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 25, 1998. Regulation: 8.