LEECO VIS-DISK STREP-A (EIA)

LEECO VIS-DISK STREP-A (EIA) is an FDA 510(k)-cleared medical device (K894122) manufactured by Leeco Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 14, 1989. Regulation: 8.