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Intl. Remote Imaging Systems
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939UDX URINE PATHOLOGY SYSTEM is an FDA 510(k)-cleared medical device (K000373) manufactured by Intl. Remote Imaging Systems. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 13, 2000. Regulation: 8.