
Roche Diagnostics
Free shipping on orders over $99 · 30-day returns
COAGUCHEK XS PLUS SYSTEM is an FDA 510(k)-cleared medical device (K071041) manufactured by Roche Diagnostics. 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 10, 2007. Regulation: 8.