
Buckman Co., Inc.
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IMAGN(TM) 2000 SYSTEM is an FDA 510(k)-cleared medical device (K945756) manufactured by Buckman Co., Inc.. 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 18, 1995. Regulation: 8.