ULTRAZYME PLUS GAMMA-GT, #64959/65032

ULTRAZYME PLUS GAMMA-GT, #64959/65032 is an FDA 510(k)-cleared medical device (K823883) 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 January 27, 1983. Regulation: 8.