CLEARVIEW ADVANCED STREP A , MODEL 737-430

CLEARVIEW ADVANCED STREP A , MODEL 737-430 is an FDA 510(k)-cleared medical device (K091489) manufactured by Binax, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 3, 2009. Regulation: 8.