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Wako Chemicals USA, Inc.
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UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION is an FDA 510(k)-cleared medical device (K100464) manufactured by Wako Chemicals USA, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 2011. Regulation: 8.