
Wako Chemicals USA, Inc.
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WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 is an FDA 510(k)-cleared medical device (K053132) manufactured by Wako Chemicals USA, 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 December 29, 2005. Regulation: 8.