Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Roche Diagnostics
Free shipping on orders over $99 · 30-day returns
COAGUCHEK XS SYSTEM is an FDA 510(k)-cleared medical device (K060978) 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 August 10, 2006. Regulation: 8.