
Helena Laboratories
Free shipping on orders over $99 · 30-day returns
AUTO AIC ANALYZER SYSTEM is an FDA 510(k)-cleared medical device (K833772) manufactured by Helena Laboratories. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 17, 1984. Regulation: 8.