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Urit Medical Electronic Co., Ltd.
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URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS is an FDA 510(k)-cleared medical device (K082811) manufactured by Urit Medical Electronic Co., Ltd.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2009. Regulation: 8.