KODAK SURECELL(TM) STREP A CONTROL FLUID SET

KODAK SURECELL(TM) STREP A CONTROL FLUID SET is an FDA 510(k)-cleared medical device (K904589) manufactured by Eastman Kodak Company. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 17, 1991. Regulation: 8.