BACT/ALERT 3D MICROBIAL DETECTION SYSTEM

BACT/ALERT 3D MICROBIAL DETECTION SYSTEM is an FDA 510(k)-cleared medical device (K981736) manufactured by Organon Teknika Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 23, 1998. Regulation: 8.