ULTRAZYME PLUS-GT, #64959 & 65032

ULTRAZYME PLUS-GT, #64959 & 65032 is an FDA 510(k)-cleared medical device (K821468) manufactured by Emd Chemicals, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 1, 1982. Regulation: 8.