ACUSYST-P (CELL CULTURE EQUIPMENT)

ACUSYST-P (CELL CULTURE EQUIPMENT) is an FDA 510(k)-cleared medical device (K864334) manufactured by Endotronics, Inc.. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 23, 1986. Regulation: 8.