IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS

IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS is an FDA 510(k)-cleared medical device (K823352) manufactured by American Dade. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 6, 1983. Regulation: 8.