BECKMAN COULTER DNASE B CALIBRATOR

BECKMAN COULTER DNASE B CALIBRATOR is an FDA 510(k)-cleared medical device (K010696) manufactured by Beckman Coulter, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 9, 2001. Regulation: 8.