
Roche Diagnostics Corp.
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COAGUCHEK XS PT CONTROLS is an FDA 510(k)-cleared medical device (K063823) 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 January 28, 2007. Regulation: 8.