BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX is an FDA 510(k)-cleared medical device (DEN070006) manufactured by Inverness Medical Professional Diagnostics-Binax. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 2007. Regulation: 8.