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

Bio-Rad, Diagnostics Grp.
Free shipping on orders over $99 · 30-day returns
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 is an FDA 510(k)-cleared medical device (K071319) manufactured by Bio-Rad, Diagnostics Grp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 2007. Regulation: 8.