CELL-DYN 22 PLUS CALIBRATOR

CELL-DYN 22 PLUS CALIBRATOR is an FDA 510(k)-cleared medical device (K111204) manufactured by Streck. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2011. Regulation: 8.