
Wako Chemicals USA, Inc.
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WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET is an FDA 510(k)-cleared medical device (K030320) 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 April 10, 2003. Regulation: 8.