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Roche Diagnostics Corp.
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COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING is an FDA 510(k)-cleared medical device (K030845) manufactured by Roche Diagnostics Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 21, 2003. Regulation: 8.