ULTRA ZYME PLUS GPT, #64956, 65035 & 36

ULTRA ZYME PLUS GPT, #64956, 65035 & 36 is an FDA 510(k)-cleared medical device (K812591) 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 September 23, 1981. Regulation: 8.