OSOM ULTRA STREP A TEST, MODEL 147

OSOM ULTRA STREP A TEST, MODEL 147 is an FDA 510(k)-cleared medical device (K992658) manufactured by Wyntek Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 17, 2000. Regulation: 8.