PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR

PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR is an FDA 510(k)-cleared medical device (K950164) manufactured by Abaxis, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 12, 1995. Regulation: 8.