BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI

BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI is an FDA 510(k)-cleared medical device (K874173) manufactured by Otisville Biopharm, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 27, 1987. Regulation: 8.