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Arkray, Inc.
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POCKETCHEM UA AUTION STICKS 10TA is an FDA 510(k)-cleared medical device (K022386) manufactured by Arkray, 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 September 16, 2002. Regulation: 8.