CELLTRACKS AUTOPREP SYSTEM MODEL:9541

CELLTRACKS AUTOPREP SYSTEM MODEL:9541 is an FDA 510(k)-cleared medical device (K100684) manufactured by Veridex, LLC. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 25, 2010. Regulation: 8.