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Tosoh Bioscience, Inc.
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G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 is an FDA 510(k)-cleared medical device (K071132) manufactured by Tosoh Bioscience, 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 September 15, 2008. Regulation: 8.