
Roche Diagnostics Corp.
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PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 is an FDA 510(k)-cleared medical device (K020831) 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 23, 2002. Regulation: 8.