
Roche Diagnostics Corp.
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PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 is an FDA 510(k)-cleared medical device (K021190) 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 October 24, 2002. Regulation: 8.