
Kyoto Diagnostics, Inc.
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KYOTEST UG URINE TEST REAGENT STRIP is an FDA 510(k)-cleared medical device (K841713) manufactured by Kyoto Diagnostics, 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 May 30, 1984. Regulation: 8.