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

Mitsubishi Kagaku Iatron
Free shipping on orders over $99 · 30-day returns
PATHFAST CK-MB-II, PATHFAST MYO-II is an FDA 510(k)-cleared medical device (K081360) manufactured by Mitsubishi Kagaku Iatron. 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 August 16, 2009. Regulation: 8.