BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010

BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 is an FDA 510(k)-cleared medical device (K083744) manufactured by Binax, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 31, 2009. Regulation: 8.