FIAX COMPLEMENT C4 TEST KIT

FIAX COMPLEMENT C4 TEST KIT is an FDA 510(k)-cleared medical device (K830669) manufactured by Intl. Diagnostic Technology. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 7, 1983. Regulation: 8.