CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800

CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 is an FDA 510(k)-cleared medical device (K973457) manufactured by Shared Systems, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 1, 1998. Regulation: 8.