GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT

GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT is an FDA 510(k)-cleared medical device (K772030) manufactured by Harleco. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 13, 1977. Regulation: 8.