COULTER ACCU-ZYME II GPT REAGENT

COULTER ACCU-ZYME II GPT REAGENT is an FDA 510(k)-cleared medical device (K790522) manufactured by Coulter Electronics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 30, 1979. Regulation: 8.