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Kawasumi Laboratories America, Inc.
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KAWASUMI LABORATORY BLOOD DRAWING KIT is an FDA 510(k)-cleared medical device (K001043) manufactured by Kawasumi Laboratories America, 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 May 18, 2000. Regulation: 8.