
R2 Diagnostics, Inc.
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THROMBO TEK PSE, MODEL 90-480 is an FDA 510(k)-cleared medical device (K082631) manufactured by R2 Diagnostics, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 16, 2008. Regulation: 8.