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

Roche Diagnostics Corp.
Free shipping on orders over $99 · 30-day returns
ELECSYS CA 19-9 CALCHECK 5 is an FDA 510(k)-cleared medical device (K101365) manufactured by Roche Diagnostics Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 4, 2010. Regulation: 8.