Elecsys CYFRA 21-1 CalCheck 5

Elecsys CYFRA 21-1 CalCheck 5 is an FDA 510(k)-cleared medical device (K162173) manufactured by Roche Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 11, 2017. Regulation: 8.