BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)

BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES) is an FDA 510(k)-cleared medical device (K860720) manufactured by Biotrack, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 22, 1986. Regulation: 8.