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Wako Chemicals USA, Inc.
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APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 is an FDA 510(k)-cleared medical device (K080125) manufactured by Wako Chemicals USA, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 17, 2008. Regulation: 8.