
Roche Diagnostics
Free shipping on orders over $99 · 30-day returns
GLUCOSE TEST SYSTEM is an FDA 510(k)-cleared medical device (K113137) manufactured by Roche Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 5, 2012. Regulation: 8.